COOK G48303Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002483033), received between Apr 7, 2016 and May 12, 2026 — classified as 22 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Material Fragmentation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COATING COMES OFF WHEN INSERTING FEED INTO THE TUBE OR CANNULA 1 PIECE KEPT, BUT ALSO THE CASE WITH OTHERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146410 ↗
• InjuryAug 29, 2023Component Incompatible; Improper or Incorrect Procedure or Method; Component Incompatible; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: BLUE PLASTIC CAME OFF THE FROVA BOUGIE WHILE INTUBATING. PATIENT OUTCOME: NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639183 ↗
• InjuryJul 27, 2023Component Incompatible; Improper or Incorrect Procedure or Method; Component Incompatible; Improper or Incorrect Procedure or Method

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17404813 ↗
• InjuryMay 16, 2023Component Incompatible; Component Incompatible

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16937808 ↗
• InjuryDec 27, 2022Component Incompatible; Flaked; Off-Label Use; Component Incompatible; Flaked; Off-Label Use

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16050126 ↗
• InjuryOct 21, 2022Component Incompatible; Migration; Component Incompatible; Migration

  ACCORDING TO INITIAL REPORTER: PIECE OF PLASTIC SHEARED OFF WHEN TUBE PLACED OVER, ENDING UP IN PATIENT'S AIRWAY.

  Patient problems: Insufficient Information

  MAUDE report 15654212 ↗
• InjuryOct 19, 2022Component Incompatible; Component Incompatible

  ACCORDING TO INITIAL REPORTER: PIECE OF PLASTIC SHEARED OFF WHEN TUBE PLACED OVER, ENDING UP IN PATIENT'S AIRWAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15630941 ↗
• InjuryApr 26, 2022Component Incompatible; Component Incompatible

  ACCORDING TO THE INITIAL REPORTER: SEVERE REFRACTORY BRONCHOSPASM FOLLOWING INDUCTION OF ANAESTHESIA WHICH FAILED TO SETTLE WITH STANDARD MEASURES. FURTHER EXAMINATION OF AIRWAY (FIBREOPTIC) DEMONSTRATED SHARDS OF THE INTUBATING CATHETER IN BOTH THE ENDOTRACHEAL TUBE AND THE RIGHT MAIN BRONCHUS. THE LATTER REQUIRED REMOVAL BY A THORACIC SURGEON. POST REMOVAL PATIENT¿S CONDITION IMPROVED AND SUCCESSFULLY UNDERWENT EMERGENT PROCEDURE THE FOLLOWING DAY. I SHOULD ALSO ADD THAT THIS IS A REPRODUCIBLE FAULT WHEREBY THE INTUBATION CATHETER SHEARS ON THE INTERNAL FLANGE ON THE ENDOTRACHEAL TUBE. THIS APPEARS TO BE A NEW FAULT WHICH HAS CAUSED THE SENIOR ANAESTHESIA BODY TO QUESTION IF THERE HAS BEEN A CHANGE IN THE PRODUCTION LINE/ MATERIALS. PATIENT ANAESTHETIZED FOR URGENT SURGERY. DEVELOPED SEVERE BRONCHOSPASM AND DIFFICULTY VENTILATING AFTER THE FROVA INTUBATING CATHETER FOUND SHEARED IN LOWER AIRWAY. SHAVINGS OF THE CATHETER DISLODGED INTO PATIENTS LOWER AIRWAY. THIS HAD CAUSED DIFFICULTY IN VENTILATION AS THE AIRWAY WAS OBSTRUCTED. MULTIPLE CONSULTANTS IN ATTENDANCE TO SALVAGE SITUATION. ATTEMPTS MADE TO RETRIEVE PARTS OF INTUBATING CATHETER (ENT/ THORACIC). SIGNIFICANT DELAYS WHILST

  Patient problems: Bronchospasm

  MAUDE report 14206282 ↗
• InjuryOct 15, 2021Component Incompatible; Off-Label Use; Component Incompatible; Off-Label Use

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: SHAVINGS OF BLUE PLASTIC FOUND IN THE PATIENTS BRONCHUS, WHEN PERFORMING BRONCHOSCOPY. ORIGINS OF PLASTIC FRAGMENTS UNCLEAR, SUSPICIOUS THAT IT MIGHT ORIGINATE FROM BLUE COOK BOUGIE - CATHETER. WE TURNED THE PATIENT INTO THE LATERAL POSITION FOR THE SECOND STAGE PART OF THE CASE. DURING THIS PROCESS OF CHECKING THE POSITION OF THE DOUBLE LUMEN TUBE, A BLUE OBJECT COULD BE SEEN IN THE RIGHT LOWER LOBE BRONCHUS. SURGICAL TEAM WERE INFORMED AND VIEWED THE OBJECT VIA THE SCOPE. SURGICAL TEAM AND ANESTHETIC TEAM DISCUSSED THIS WITH THE THORACIC SURGEON. THE DECISION WAS MADE TO REMOVE AND RETRIEVE THE FOREIGN OBJECT VIA A BRONCHOSCOPY. THORACIC SURGEON CHECKED THE LEFT LOBE AND MORE PLASTIC WAS RETRIEVED. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638050 ↗
• InjurySep 23, 2021Component Incompatible; Off-Label Use; Component Incompatible; Off-Label Use

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517668 ↗
• InjuryFeb 18, 2021Off-Label Use; Component Incompatible; Off-Label Use

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: SETTING UP FOR A DOUBLE LUMEN PROCEDURE, 7FR DOUBLE LUBE WAS BEING PREPARED BY ANESTHESIOLOGIST AND RESIDENT. A 14FR FROVA INTUBATING CATHETER WAS PLACED INSIDE THE BRONCHIAL LUMEN TO TEST FOR FIT. RT NOTED AND VOCALIZED THAT FROVA DID NOT MOVE SMOOTHLY WITHIN THE LUMEN AND MENTIONED THAT A 11FR EXCHANGE CATHETER WAS AVAILABLE. ANESTHETIST REMOVED FROVA CATHETER AND RE-STYLETTED DOUBLE LUMEN IN ANTICIPATION OF INTUBATION. INTUBATION PERFORMED AND FROVA CATHETER NOT USED. ONCE PLACEMENT OF DOUBLE LUMEN, SCOPE USED TO VISUALIZE AIRWAY PLACEMENT. BRIGHT BLUE FOREIGN OBJECT NOTED IN AIRWAY. REMOVED PROMPTLY BY THORACIC SURGEON VIA SUCTION ON BRONCHOSCOPE. FOREIGN BODY PLACED IN SPECIMEN CONTAINER AND PASSED ALONG TO SITE LEAD ALONG WITH FROVA CATHETER. PATIENT OUTCOME: NO APPARENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 11341639 ↗
• InjuryJul 15, 2020Component Incompatible

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275331 ↗
• MalfunctionNov 21, 2019Difficult to Advance; Difficult to Advance

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS STYLET DOES NOT MEET THE DEMANDS OF A DIFFICULT INTUBATION, SEMI RIGID, ANTERIOR ARTICULATION, TOO FLEXIBLE AND MALLEABLE. THE BOUGIE DOESN'T MEET THE REQUIREMENTS OF A DIFFICULT INTUBATION. SEMI STIFFNESS, ANTERIOR BENDING, TOO SOFT AND MALLEABLE. VITAL RISK IN CASE OF DIFFICULT AIRWAY INTUBATION. THE BOUGIE CROUCHES IN THE OTHER DIRECTION AS IT TOUCHES AN OBSTACLE. IF YOU COULDN'T INTUBATE , YOU HAVE A RISK OF DEATH OF THE PATIENT, YOU HAVE TO USE OTHER DEVICE TO HELP YOU: VIDEOLARYNGOSCOPY, FASTRACK, MELKER CRICOTHYROTOMIES SET ¿IT HAPPENED TWICE¿. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353343 ↗
• MalfunctionNov 21, 2019Difficult to Advance; Difficult to Advance

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS STYLET DOES NOT MEET THE DEMANDS OF A DIFFICULT INTUBATION, SEMI RIGID, ANTERIOR ARTICULATION, TOO FLEXIBLE AND MALLEABLE. THE BOUGIE DOESN'T MEET THE REQUIREMENTS OF A DIFFICULT INTUBATION. SEMI STIFFNESS, ANTERIOR BENDING, TOO SOFT AND MALLEABLE. VITAL RISK IN CASE OF DIFFICULT AIRWAY INTUBATION. THE BOUGIE CROUCHES IN THE OTHER DIRECTION AS IT TOUCHES AN OBSTACLE. IF YOU COULDN'T INTUBATE , YOU HAVE A RISK OF DEATH OF THE PATIENT, YOU HAVE TO USE OTHER DEVICE TO HELP YOU: VIDEOLARYNGOSCOPY, FASTRACK, MELKER CROCOTHYROTOMIE SET ¿IT HAPPENED TWICE¿. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353182 ↗
• InjuryFeb 27, 2019Scratched Material; Scratched Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8373022 ↗
• InjuryDec 5, 2018Material Frayed; Material Frayed

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Information

  MAUDE report 8132379 ↗
• InjuryJun 25, 2018Material Frayed; Material Frayed

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2018, IT WAS NOTICED A PEELING OF THE GUIDE DURING A FIBROSCOPIC CHECK UP POST ENDOBRONCHIAL INTUBATION. THE "PEELING" WAS REMOVED AND KEPT WITHOUT ANY OTHER PARTICULAR ISSUE BEING NOTICED. "DIFFICULT INTUBATION REQUIRED THE USE OF TYPE COOK TUBE, WITHOUT DIFFICULTY DURING USE. A FIBROSCOPIC CHECK IMMEDIATELY AFTER THE INTUBATION HELPED TO DISPLAY AN ENDOBRONCHIAL FOREIGN MATTER, WHICH ACCORDING TO THE DEPARTMENT REPORTER, WOULD BE ¿PEELING¿ OF THE TUBE. THE PROBE USED WAS A CARLENS SHILEY 39F PROBE, FROM COVIDIEN. THIS INCIDENT HAPPENED SEVERAL TIMES". SELECTIVE INTUBATION; IT IS A MISUSE OF THE DEVICE, THEY USE DOUBLE LUMEN ETT INSTEAD OF SINGLE LUMEN. PATIENT OUTCOME: "CLINICAL CONSEQUENCES REPORTED ARE MODERATE. INCREASE OF INTUBATION PERIOD"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7633191 ↗
• MalfunctionMar 6, 2018Scratched Material; Scratched Material

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN REMOVING THE FROVA BOUGIE AFTER PLACING A DOUBLE LUMEN ET TUBE, A SHAVING OF THE FROVA CAME OFF THE FROVA BUT WAS STILL ATTACHED AND SO WAS REMOVED WITH THE FROVA. DETAILS OF INCIDENT: "14 FR. COOK FROVA INTUBATING CATHETER (BOUGIE) WAS USED TO INTUBATE USING A 39CH DOUBLE LUMEN TUBE. THE BOUGIE IS COMPOSED OF BLUE PLASTIC MATERIAL AND SOME OF THIS SCRAPED OFF WHILE IT WAS BEING REMOVED FROM THE PATIENT'S AIRWAY. NO ASPIRATION OF THE DISLODGED FRAGMENT OCCURRED BUT THIS IS A POTENTIAL RISK IN THIS SCENARIO". USE OF THE THORACIC SPECIFIC BOUGIE RECOMMENDED FOR NOW, HOWEVER NO REASON TO SUSPECT THAT THIS COULDN¿T HAPPEN WITH A STANDARD ETT. MTOS INFORMED". PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NATURE OF INJURY: NONE OCCURRED BUT A SIMILAR INCIDENT OCCURRED LAST WEEK WHEN A PLASTIC FRAGMENT WAS DISPLACED INTO THE AIRWAY AND A BRONCHOSCOPY WAS REQUIRED TO RETRIEVE IT. NO ASPIRATION OF THE DISLODGED FRAGMENT OCCURRED BUT THIS IS A POTENTIAL RISK IN THIS SCENARIO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7315679 ↗
• MalfunctionJan 11, 2018Scratched Material; Scratched Material

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: CHANGE OF INTUBATION CATHETER ON (B)(4). DURING FIBROSCOPIC CONTROL, ABLATION OF A FOREIGN BODY OF BLUE COLOR, CORRESPONDING TO A PIECE OF (B)(4). PHYSICIAN USE THE FROVA FOR EXCHANGE A DOUBLE LUMEN TUBE 39 G FOR A SMALLER ONE 37. HE FOUND SOME SMALL PIECES OF THE FROVA, BLUE COLOR, DURING FIBROSCOPIC CONTROL AND THEY REMOVED THE PIECES. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181523 ↗
• MalfunctionNov 30, 2017Scratched Material; Scratched Material

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT WAS REPORTED THAT A COOK FROVA CATHETER WAS USED TO ASSIST WITH PLACING A MEDTRONIC SHILEY BRONCHOCATH 39L DOUBLE LUMEN ETT. ON BRONCHOSCOPY AFTER INTUBATION A PLASTIC FOREIGN BODIES WAS FOUND IN THE MAIN BRONCHUS. THE FOREIGN BODY WAS PLASTIC COATING OFF THE FROVA CATHETER WHICH HAD SHEARED OFF WHEN PLACED VIA THE DLETT. THE PROBLEM RESOLVED WITH A FRESH CATHETER AND DLETT ¿ON THE BENCH¿. THE FROVA CATHETER APPEARS TO HAVE AN OUTERCOATING WHICH EASILY SHAVES OFF ON ANY EDGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7069916 ↗
• InjuryMay 18, 2017Break; Break

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: MANDRIN MOUNTED ON SELECTIVE INTUBATION LEFT CATHETER 37F, FOR CATHETERISM OF THE PRIMARY BRONCHI, THEN TAKEN OUT. AT THE RETRIEVAL, IT WAS NOTICED AN ALTERATION OF THE INTEGRITY OF THE DISTAL END OF THE MANDRIN. DURING THE SCOPE TEST, A CHIPPING IS FOUND IN THE TRACHEA . THE PULMONOLOGIST WERE CALLED TO PERFORM AN ACT OF RIGID FIBROSCOPY AND RETRIEVAL OF THE CHIPPING IN THE TRACHEA. ADDITIONAL INFORMATION RECEIVED 26APR2017: "IT IS A DOUBLE LUMEN USE. A BRONCHOCATH 37G FOR SELECTIVE INTUBATION." PATIENT OUTCOME: NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574635 ↗
• InjuryApr 11, 2017Scratched Material; Scratched Material

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING FIBROSCOPIC CONTROL: A CHIP OF THE DEVICE WAS FOUND. FIBROSCOPIC ASPIRATION AND RETRIEVAL OF THE FRAGMENT. ADDITIONAL INFORMATION RECEIVED 04APR2017: INTUBATION ON GUIDE BY BRONCHOCATHETER 37G WITHOUT SPUR LUBRICATED WITHOUT PROBLEM. DURING FIBROSCOPIC CONTROL: A CHIP OF THE DEVICE WAS FOUNDED. FIBROSCOPIC ASPIRATION AND RETRIEVAL OF THE FRAGMENT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6479556 ↗
• InjuryApr 3, 2017Flaked; Material Frayed; Flaked; Material Frayed

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DOUBLE LUME TUBE HAS BEEN INTRODUCED VIA FROVA. SPLINTERS CAME OF FROVA. HAVE BEEN RETRIEVED VIA BRONCHOSCOPE. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PRODUCT CAUSED OR CONTRIBUTED TO THE NEED FOR ADDITIONAL PROCEDURES. SPLINTERS COULD BE REMOVED WITHOUT ANY FURTHER CONSEQUENCES. NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6452639 ↗
• MalfunctionApr 3, 2017Flaked; Material Frayed; Flaked; Material Frayed

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT WAS INTUBATED WITH THE DOUBLE LUMEN TUBE OVER THE FIC ALTHOUGH THIS IS AGAINST IFU'S. ON EXAMINING THE AIRWAY WITH THE FIBREOPTIC SCOPE TO CHECK THE TUBE PLACEMENT, A FLAKE OF THE BLUE CATHETER MATERIAL WAS SEEN IN THE PATIENT TRACHEA. I EXPLAINED TO THE NURSE MANAGER OUR IFU'S WERE REVISED SEVERAL YEARS AGO BUT AS WE WERE NOT SELLING DIRECTLY IN IRELAND THERE IS A POSSIBILITY THE CHANGE IN IFU'S MAY NOT HAVE BEEN PROPERLY COMMUNICATED ADDITIONAL INFORMATION RECEIVED 15MAY2012: "THE PATIENT WAS INTUBATED WITH THE DOUBLE LUMEN TUBE (ENDOBRONCHIAL TUBE) OVER THE FIC ALTHOUGH THIS IS AGAINST IFU'S. REP EXPLAINED TO THE NURSE MANAGER OUR IFU'S WERE REVISED SEVERAL YEARS AGO." PATIENT OUTCOME: THE FLAKE OF MATERIAL WAS REMOVED USING THE SUCTION CHANNEL OF THE SCOPE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6452635 ↗
• InjuryApr 3, 2017Break; Break

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: SMALL PIECE OF CATHETER DETACHED FROM OXYGENATING LUMEN AT DISTAL TIP OF CATHETER WAS OBSERVED IN PATIENT'S LEFT BRONCHIAL SYSTEM DURING FIBREOPTIC CHECKING OF DOUBLE LUMEN TRACHEAL TUBE. REQUIRED RIGID BRONCHOSCOPY FOR RETRIEVAL. ON EXAMINATION THIS COULD NOT BE SEEN WITH THE NAKED EYE ON THE CATHETER. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6452634 ↗