NexSite HD Hemodialysis Catheter NEXHD1552801Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05391525640020), received between Dec 3, 2015 and Jun 12, 2017 — classified as 3 deaths, 23 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2017Adverse Event Without Identified Device or Use Problem

  (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT EXPERIENCED A RECURRENCE OF SVC (SUPERIOR VENA CAVA) SYNDROME THAT WAS SEVERE IN NATURE. HE WAS HOSPITALISED FROM (B)(6) 2017. HE PRESENTED WITH SYMPTOMS OF RIGHT NECK AND SHOULDER SWELLING, SWOLLEN FACE, SYNCOPE AND NASAL CONGESTION. THE DEVICE WAS REMOVED AND THE EVENT HAD RESOLVED ON (B)(6) 2017. THIS PATIENT HAD A HISTORY OF SVC SYNDROME AND A FEMORAL CATHETER WAS NEEDED.

  Patient problems: Nasal Obstruction; Swelling; Syncope

  MAUDE report 6633011 ↗
• MalfunctionMay 29, 2017Insufficient Flow or Under Infusion

  (B)(4). THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 017. ON (B)(6) 2017, THE PATIENT EXPERIENCED POOR FLOW OF THE HAEMODIALYSIS CATHETER THAT WAS MILD IN SEVERITY. NO ACTION WAS TAKEN WITH THE STUDY DEVICE AND THE EVENT RESOLVED ON THE SAME DAY AFTER TREATMENT WITH ALTEPLASE.

  Patient problems: No Information

  MAUDE report 6596447 ↗
• InjuryMay 22, 2017Adverse Event Without Identified Device or Use Problem

  CONCLUSION OF THE CEC (CLINICAL EVENTS COMMITTEE) FOLLOWING ADJUDICATION OF THE ADVERSE EVENT: INFECTION - NO DEVICE RELATIONSHIP. APPEARS THAT THIS WAS NOT CRBSI BASED ON NEGATIVE BLOOD CULTURES BEFORE VANCOMYCIN.

  Patient problems: Chills; Fever

  MAUDE report 6581040 ↗
• InjuryMay 2, 2017Adverse Event Without Identified Device or Use Problem

  STUDY (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2015. IT WAS REPORTED THAT THE SUBJECT CAME TO VASCULAR ACCESS UNIT ON (B)(6) 2015 FOR A CATHETER REMOVAL DUE TO ACCESS NO LONGER NEEDED/VIABLE FISTULA IN PLACE. UPON BEING QUERIED ABOUT ANTIBIOTICS BY MONITOR ON (B)(6) 2016, STUDY COORDINATOR NOTED THAT ANTIBIOTICS VANCOMYCIN AND CEFEPIME WERE ADMINISTERED DUE TO MODERATE DRAINAGE PRIOR TO DEVICE REMOVAL ON (B)(6) 2015. THE SITE MONITORING VISIT IN (B)(6) 2017 REFERENCED DRAINAGE AROUND THE DISC HAD RESULTED IN DEVICE REMOVAL. PATIENT RECORDS INDICATED THAT THE PATIENT PRESENTED WITH COMPLAINTS OF SEVERE PAIN TO THE RIGHT SIDE OF HIS NECK NEAR CATH. CATH DISK HAS SMALL OPENING AT THE TOP, AND HAS TAN DISCHARGE. NO EVIDENCE OF PURULENT DISCHARGE. THE EVENT HAD RESOLVED ON THE SAME DATE ((B)(6) 2015). DRESSINGS WERE APPLIED TO THE CANNULATION SITES WHICH WERE DRY AND INTACT AT TIME OF DISCHARGE.

  Patient problems: Fluid Discharge; Pain

  MAUDE report 6536329 ↗
• InjuryMar 7, 2017Hole In Material; Device Contamination with Chemical or Other Material

  (B)(4): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2017, A CATHETER MALFUNCTION PRESENTED AS HAVING POOR BLOOD FLOWS DURING THE DIALYSIS SESSION. THE CATHETER WAS REPLACED WITH ANOTHER ONE (NOT A NEXSITE HD CATHETER) AND THE EVENT RESOLVED ON THE SAME DATE. SUBJECT IS NOW DIALYSING WELL WITH NO COMPLICATIONS. THE PROCEDURE NOTE STATES THAT THERE WAS A FIBRIN SHEATH IN THE BRACHIOCEPHALIC VEIN IN ADDITION TO THERE BEING A "HOLE" IN THE CATHETER.

  Patient problems: No Code Available

  MAUDE report 6383312 ↗
• InjuryFeb 8, 2017Insufficient Device Problem Information

  (B)(4): ADDITIONAL INFORMATION PROVIDED BY MONTHLY SITE MONITORING VISIT INDICATED METABOLIC ACIDOSIS IN THE PAST MEDICAL HISTORY.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 6310146 ↗
• InjuryJan 10, 2017Device Dislodged or Dislocated

  STUDY (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. SUBJECT WAS GIVEN STANDARD POST PROCEDURE CARE INSTRUCTIONS WHICH INCLUDE TO SEEK IMMEDIATE MEDICAL ATTENTION SHOULD EXCESSIVE BLEEDING OCCUR. LATER THAT DAY (ABOUT 5 HOURS AFTER PROCEDURE), THE SUBJECT ATTENDED THE EMERGENCY DEPARTMENT. THE ED RESIDENT MENTIONS THAT THE SUBJECT TOLD THEM THAT THE CATHETER "TUGGED SHIRT AND SINCE THEN HAS BEEN SLOWLY BLEEDING". THE NEPHROLOGIST RECOMMENDED OVERNIGHT OBSERVATION STAY WITH DIALYSIS PLANNED FOR THE MORNING. NEPHROLOGIST NOTED THE PERMCATH SITE LOOKED OK AND PLACEMENT WAS CONFIRMED ON X-RAY. CONSULTATION NOTE MENTIONED SUBCUTANEOUS BLEEDING INTO TUNNEL TRACT. SUBJECT WAS GIVEN EMPIRIC DOSE OF ANCEF 2 GRAMS WITH HEMODIALYSIS TREATMENT. NO FEVER WAS NOTED AND NO OTHER SIGNS/SYMPTOMS OF INFECTION MENTIONED. SUBJECT'S BLEEDING WAS CONTROLLED WITH VITAMIN K, DESMOPRESSIN, LOCAL COMPRESSION AND ICE PACKS. THE SUBJECT WAS DISCHARGED IN A SATISFACTORY CONDITION. THE EVENT HAD RESOLVED ON (B)(6) 2016. THE TRACTION FROM THE SHIRT PULLING ON THE CATHETER COULD DEFINITELY EXPLAIN WHY IT WAS BLEEDING AGAIN AFTER THE SUCCESSFUL PLACEMENT. NO SUBJECT WOULD HAVE BEEN DISCHARGED A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6236070 ↗
• InjuryDec 19, 2016Insufficient Device Problem Information

  STUDY (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016 THE SUBJECT EXPERIENCED A MODERATE FEVER (99.5) WITH A POSSIBLE DEVICE RELATIONSHIP. THE SUBJECT HAD AN AVG (ARTERIOVENOUS GRAFT) PLACED ON (B)(6) 2016. TREATMENT FOR THE EVENT INCLUDED VANCOMYCIN AND CEFTAZIDIME. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. CENTRAL BLOODS WERE NEGATIVE. THE EVENT HAD RESOLVED ON (B)(6) 2016. THE PATIENT'S TEMPERATURE HAD RETURNED TO NORMAL RANGE (95.6) AND THERE WERE NO MORE COMPLAINTS FROM THE SUBJECT.

  Patient problems: Fever

  MAUDE report 6184813 ↗
• MalfunctionDec 12, 2016Insufficient Flow or Under Infusion

  (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT EXPERIENCED MODERATE POOR FLOW. THE DEVICE WAS REMOVED WAS (B)(6) 2016 AND THE EVENT RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6165674 ↗
• InjuryDec 8, 2016Adverse Event Without Identified Device or Use Problem

  STUDY TR (B)(4): THE NEXSITE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, A "DISK" INFECTION WAS REPORTED. THE SUBJECT PRESENTED TO THE DIALYSIS UNIT WITH PUS DRAINAGE COMING FROM AN AREA APPROX. 1/2 INCH FROM THE PERM CATH EXIT SITE. WOUND CULTURE AND BLOOD CULTURES X 2 WERE DRAWN. THE DEVICE WAS REMOVED ON THE SAME DAY AND THE EVENT RESOLVED. ANTIBIOTICS WERE GIVEN AFTER THE DEVICE WAS REMOVED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 6154083 ↗
• InjuryDec 8, 2016Occlusion Within Device

  STUDY (B)(4): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WENT TO THE VASCULAR CLINIC BECAUSE NEXSITE CATHETER HAD CLOTTED THE DAY PRIOR AND THE PATIENT REQUIRED NEW ACCESS FOR HEMODIALYSIS. A COVIDIEN PALINDROME CATHETER WAS THEN PLACED. THE EVENT HAD RESOLVED ON THE SAME DAY.

  Patient problems: No Code Available

  MAUDE report 6154082 ↗
• InjuryDec 1, 2016Migration or Expulsion of Device

  STUDY (B)(6): DURING PLACEMENT OF THIS NEXSITE DEVICE ON (B)(6) 2016, THE CUFF DISPLACED FROM THE CATHETER. FURTHER DETAILS PROVIDED INDICATED THAT THE CATHETER CUFF WAS MOVING ON THE CATHETER SHAFT IN THE DIRECTION OF THE BIFURCATION JOINT. THE DOCTOR DID NOT HAVE THE OPTION OF REPLACING THE CATHETER BECAUSE THIS CATHETER LENGTH WAS NOT IN STOCK. THE DOCTOR INDICATED THAT HE USED A TISSUE GLUE FOR WOUND HEALING (CYANOACRYLATE) TO BOND THE CUFF TO THE CATHETER AND PLACED ADHESIVE CIRCUMFERENTIALLY AT EITHER END OF THE CUFF. HE INDICATED THAT THIS GAVE A GOOD BOND AND ENABLED HIM TO POSITION THE CATHETER IN THE DISC AS PER THE PLACEMENT DIRECTIONS IN THE DFU.

  Patient problems: No Code Available

  MAUDE report 6137581 ↗
• DeathNov 10, 2016Insufficient Device Problem Information

  THE SITE HAS BEEN UNABLE TO GET A DEATH CERTIFICATE. THE DIALYSIS UNIT DID SEND OVER A REPORT WHICH STATES THE CAUSE OF DEATH AS "UNKNOWN". THE PATIENT WAS HOSPITALISED FOR THE SEPSIS EVENT THAT OCCURED ON (B)(6) 2016.

  Patient problems: Anemia; Atrial Fibrillation; Bradycardia; Cardiac Arrest; Congestive Heart Failure; Death; Hypoglycemia; Loss Of Pulse; Low Blood Pressure/ Hypotension; Malaise; Nausea; Sepsis; Unspecified Infection

  MAUDE report 6092072 ↗
• InjuryOct 26, 2016Insufficient Device Problem Information

  (B)(6): THE NEXSITE DEVICE WAS PLACED SUCCESSFULLY ON (B)(6) 2016. AT HER 90 DAY REVIEW ON (B)(6) 2016, THERE WAS NO REPORT OF ANY ADVERSE EVENT. ON (B)(6) 2016, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT COMPLAINING OF CHEST PAIN TO TOUCH AND DRAINAGE FROM HER DIALYSIS PORT ON THE RIGHT SIDE OF HER CHEST. PATIENT DESCRIBES HER PORT TO BE "OOZING AND PAINFUL" AND ALSO COMPLAINS OF CHILLS AND VOMITING GREEN FLUIDS. SHE ADMITS TO MISSING HER MOST RECENT DIALYSIS APPOINTMENTS DUE TO A FEVER FOLLOWING A FLU SHOT 4-5 DAYS AGO. ON EXAMINATION OF THE SKIN, SEROUS FLUID WITH BLOODY TINGE, SLIGHTLY PURULENT DRAINAGE WITH MODERATE SWELLING AND MILD ERYTHEMA TO RIGHT CHEST DIALYSIS PORT WAS REPORTED. PUS WAS EXPRESSED FROM AROUND THE PORT AND SWABBED AND SENT FOR CULTURE. (B)(6) WAS REPORTED IN THE WOUND CULTURE. THIS PATIENT HAD A HISTORY OF SKIN (B)(6). BLOOD CULTURES WERE ALSO OBTAINED BUT THESE RESULTS ARE NOT AVAILABLE. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. GIVEN THE LACK OF FEVER, THE PATIENT BEING RELATIVELY WELL-APPEARING AND THE WHITE COUNT BEING ONLY 13.1, EMPIRIC TREATMENT WITH INVANZ WAS RECOMMENDED. DOXCYCLINE WAS STARTED ON (B)(6) 2016. LASIX WAS ALSO GIVEN TO DECREA

  Patient problems: Chest Pain; Chills; Erythema; Hemorrhage/Blood Loss/Bleeding; Pain; Purulent Discharge; Swelling; Unspecified Infection; Vomiting

  MAUDE report 6056528 ↗
• InjuryOct 24, 2016Insufficient Device Problem Information

  THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, THE SUBJECT REPORTED TO THE DIALYSIS UNIT. THE ROUNDING DOCTOR NOTED THAT THERE WAS A PUSTULE AT THE CATHETER SITE. WOUND AND BLOOD CULTURES WERE TAKEN AND ANTIBIOTICS WERE STARTED. TREATMENT FOR THE EVENT INCLUDED CEFTAZIDIME AND VANCOMYCIN. THE DEVICE WAS REMOVED ON (B)(6) 2016 FOR A SUSPECTED/CONFIRMED CRBSI EVENT. THE PATIENT IS CURRENTLY USING A NEW CATHETER FOR HD TREATMENT.

  Patient problems: Post Operative Wound Infection; Purulent Discharge

  MAUDE report 6050147 ↗
• InjuryOct 24, 2016Obstruction of Flow

  (B)(4): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED IN THIS PATIENT ON (B)(6) 2016. PER THE STAFF AT THE DIALYSIS UNIT, THE PATIENT REPORTED TO DIALYSIS ON (B)(6) 2016 WITH A CLOTTED ACCESS AND MILD POOR FLOW. ACTIVASE WAS GIVEN TO TREAT THE EVENT. THE PATIENT HAD HIS CATHETER REMOVED DUE TO THIS EVENT ON (B)(6) 2016 AND THE EVENT HAD RESOLVED ON THE SAME DATE.

  Patient problems: No Code Available

  MAUDE report 6050144 ↗
• MalfunctionSep 20, 2016Device Dislodged or Dislocated

  (B)(4): THE NEXSITE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. APPROXIMATELY FOUR MONTHS' LATER, THE PATIENT'S AV ACCESS HAD BEEN SUCCESSFULLY CANNULATED AND SHE WAS SCHEDULED FOR CATHETER REMOVAL. ON (B)(6) 2016 (THE NIGHT BEFORE THE CATHETER REMOVAL), SHE WAS REMOVING HER CLOTHES AND INADVERTENTLY DISLODGED HER CATHETER. SHE WENT TO THE EMERGENCY ROOM WHERE THE TRIAGE DESK TOLD HER THE CATHETER WAS OUT AND THERE WAS NOTHING THEY NEEDED TO DO. THEY DID NOT EVEN EVALUATE HER, BUT DISPOSED OF THE CATHETER LIMBS FOR HER. NO TREATMENT WAS NECESSARY BECAUSE THERE WAS NO BLEEDING. THE NEXT DAY SHE PRESENTED AS SCHEDULED IN ORDER TO HAVE HER DISC REMOVED. THE DISC WAS REMOVED WITHOUT PROBLEMS. SHE CONTINUES TO USE HER AV ACCESS FOR DIALYSIS TREATMENTS. THE EVENT HAD RESOLVED. THERE WERE NO HEALTH CONSEQUENCES WHATSOEVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5962569 ↗
• InjuryJun 23, 2016Device Operates Differently Than Expected

  (B)(4): THE NEXSITE DEVICE WAS PLACED SUCCESSFULLY ON (B)(6) 2016. STARTING ON (B)(6) 2016, IT WAS NOTED SEVERAL TIMES DURING THE MONTH THAT THIS SUBJECT WAS HAVING TROUBLE WITH THE SYSTEM CLOTTING. THE NOTE FROM (B)(6) 2016 STATES "HAD TO BE FLUSHED NUMEROUS TIMES THROUGHOUT TREATMENT TO PREVENT CLOTTING. TOLERATED TREATMENT WELL. DISCHARGE STABLE WITHOUT COMPLAINT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5743976 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem

  (B)(4): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED IN THIS PATIENT ON (B)(6) 2016. ON (B)(6) 2016, A MODERATE INFECTION WAS REPORTED. THE PATIENT COMPLAINED OF BEING SICK AND HER ABDOMINAL PAIN WHILE ATTENDING DIALYSIS. SHE SPAT UP SALIVA WITH BROWN STREAKS. BLOOD CULTURES WERE TAKEN THAT DAY AND THE PATIENT ATTENDED THE EMERGENCY DEPARTMENT WHERE SHE WAS DIAGNOSED WITH CHRONIC ABDOMINAL PAIN WITH EPISODES OF VOMITING. THE SUBJECT RETURNED TO DIALYSIS ON (B)(6) 2016 WITH A TEMPERATURE OF 99.2F. CATHETER CARE WAS PERFORMED AND THERE WERE NO REPORTED SIGNS OF INFECTION. BLOOD WAS OBTAINED THAT DAY FOR BLOOD CULTURES AS WELL DUE TO THE PATIENT'S CONTINUOUS NAUSEA AND VOMITING. THESE BLOODS SHOWED COAGULASE (B)(6). THE DEVICE WAS REMOVED ON (B)(6) 2016 AND VANCOMYCIN WAS GIVEN. THE EVENT RESOLVED ON THE SAME DATE.

  Patient problems: Abdominal Pain; Nausea; Unspecified Infection; Vomiting

  MAUDE report 5690606 ↗
• DeathMay 26, 2016Insufficient Device Problem Information

  STUDY (B)(4): THE STUDY DEVICE WAS SUCCESSFULLY PLACED IN THIS (B)(6) MALE PATIENT ON (B)(6) 2015. THE PATIENT DIED ON (B)(6) 2016. PER THE DEATH CERTIFICATE THE IMMEDIATE CAUSE OF DEATH WAS RENAL CANCER METASTATIC. END STAGE RENAL DISEASE WAS LISTED AS AN UNDERLYING CAUSE OF DEATH. THE DEATH WAS UNRELATED TO THE STUDY DEVICE.

  Patient problems: Cancer; Death

  MAUDE report 5681246 ↗
• InjuryMay 12, 2016Insufficient Device Problem Information

  (B)(6). THE DEVICE WAS SUCCESSFULLY PLACED IN THIS (B)(6) YEAR OLD MALE ON (B)(6) 2016. ON (B)(6) 2016, A POSSIBLE EXIT SITE INFECTION WAS REPORTED. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. VANCOMYIN WAS GIVEN TO TREAT THE EVENT. NO WOUND CULTURES WERE DRAWN. HOWEVER, BLOOD CULTURES WERE DRAWN AND THE RESULTS WERE "NO GROWTH AFTER FIVE DAYS OF INCUBATION". PER THE NURSE, THE PATIENT STILL HAD SOME DRAINAGE AS OF (B)(6) 2016; THE LAST TIME THE SUBJECT WAS SEEN FOR DIALYSIS. THE DEVICE WAS REMOVED ON (B)(6) 2016 AS IT WAS NO LONGER REQUIRED.

  Patient problems: Unspecified Infection

  MAUDE report 5649707 ↗
• InjuryMay 10, 2016Insufficient Device Problem Information

  STUDY (B)(4): THE DEVICE WAS SUCCESSFULLY PLACED IN THIS (B)(6) MALE PATIENT ON (B)(6) 2015. ON (B)(6) 2016, A MODERATE CLOTTING ISSUE/THROMBOSIS OCCURRED. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. ALTEPLASE WAS GIVEN TO DE-CLOT. THE EVENT HAD RESOLVED ON (B)(6) 2016.

  Patient problems: Thrombosis

  MAUDE report 5643124 ↗
• MalfunctionMay 10, 2016Improper Flow or Infusion

  THE PATIENT HAD HER DEVICE REMOVED ON (B)(6) 2016 DUE TO FLOW ISSUES. THE ORIGINAL FLOW ISSUES WERE THOUGHT TO BE RESOLVED AFTER A DOSE OF CATHFLO BUT ENDED UP CONTINUING. THE DEVICE WAS DISPOSED OF AFTER REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5643108 ↗
• InjuryApr 29, 2016Infusion or Flow Problem

  STUDY (B)(6): THE NEXSITE WAS SUCCESSFULLY PLACED IN THIS (B)(6) MALE PATIENT ON (B)(6) 2015. ON (B)(6) 2016, THE PATIENT HAD A CATHETER THROMBOSIS / A MILD CATHETER FLOW ISSUE. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. CATHFLO ACTIVASE WAS GIVEN TO DE-CLOT AND THE EVENT RESOLVED ON THE SAME DATE.

  Patient problems: Thrombosis

  MAUDE report 5619118 ↗
• InjuryApr 7, 2016Contamination

  (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED IN THIS (B)(6) FEMALE ON (B)(6) 2016. ON (B)(6) 2016, AN MODERATE INFECTION WAS REPORTED. CENTRAL BLOODS TESTED POSITIVE FOR (B)(6). VANCOMYCIN WAS GIVEN TO TREAT THE EVENT. THE EVENT HAD RESOLVED ON (B)(6) 2016. THE DEVICE WAS REMOVED FROM THE PATIENT ON (B)(6) 2016 AS IT WAS NO LONGER REQUIRED.

  Patient problems: Bacterial Infection

  MAUDE report 5553829 ↗