Fuhrman G55714Recalls & reported problems
Cook Incorporated · Fuhrman Pleural/Pneumopericardial Drainage Set · Class 1
All models of Fuhrman (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002557147), received between May 11, 2016 and Oct 21, 2024 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow3
- Break1
- Detachment of Device or Device Component1
- Device Damaged Prior to Use1
- Insufficient Flow or Under Infusion1
- Manufacturing, Packaging or Shipping Problem1
- Material Separation1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Thrombosis/Thrombus2
- Foreign Body In Patient1
- Hypoxia1
- Insufficient Information1
- Low Oxygen Saturation1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2024Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Thrombosis/Thrombus
MAUDE report 20498533 ↗InjuryMay 3, 2024Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus
MAUDE report 19242934 ↗MalfunctionNov 13, 2023Obstruction of Flow; Manufacturing, Packaging or Shipping Problem; Obstruction of Flow; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18120760 ↗InjuryJun 1, 2023Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion
PER ADDITIONAL INFORMATION PROVIDED ON 08JUN2023, THE CUSTOMER REPORTED THE PATIENT "HAD A ROUGH NIGHT" TO MEAN THE PATIENT EXPERIENCED RESPIRATORY FAILURE IN WHICH THERE WAS SIGNIFICANT REFRACTORY HYPOXIA AND HYPERCARBIA WITH SATURATION BELOW 40 FOR AT LEAST 30 MINUTES CONTINUOUSLY. IT WAS ALSO NOTED THERE WAS A REFRACTORY AIR LEAK WITH CONTINUOUS MANUAL EVACUATION OF AIR. A NEW CHEST TUBE WAS PLACED AND THE PATIENT EXPERIENCED DRAMATIC STABILIZATION WITH THE INITIATION OF INHALED NITRIC OXIDE. HOWEVER, THE FRACTURED PORTION OF THE DEVICE HAS NOT YET TO BE REMOVED.
Patient problems: Foreign Body In Patient; Hypoxia; Low Oxygen Saturation; Respiratory Failure
MAUDE report 17042337 ↗MalfunctionDec 21, 2021Break; Break
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 13051652 ↗MalfunctionMar 27, 2018Device Damaged Prior to Use
IT WAS REPORTED THAT THE FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET SPLIT UPON OPENING THE PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7374946 ↗MalfunctionMay 11, 2016Detachment of Device or Device Component; Detachment of Device or Device Component
THE COOK PIGTAIL CHEST DRAIN WAS PLACED ON A PRETERM BABY. THE DRAIN SNAPPED OFF AT THE SITE OF THE HUB AWAY FROM THE PATIENT 5 DAYS LATER. THE DRAIN WAS CLAMPED WITH FORCEPS THEN REMOVED. THE PATIENT DID NOT COME TO ANY HARM AS A RESULT OF THIS INCIDENT. THE REPORTER STATES IT WAS THE FIRST TIME THEY HAVE COME ACROSS THIS TYPE OF INCIDENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT铠BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5646734 ↗
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- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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