HAKIM PERITON CATH,120CM
Report
- Report Number
- 3013886523-2025-00081
- Event Type
- Injury
- Date Received
- April 22, 2025
- Date of Event
- March 25, 2025
- Report Date
- November 18, 2025
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- PMA / PMN Number
- K944222
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE HAKIM PERITONEAL CATHETER (ID 823045) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
ADDITIONAL INFORMATION: "IN 2020, ABDOMINAL CYST WAS FORMED. THE DOCTOR PUNCTURED AND REMOVED THE ACCUMULATED FLUID IN THE CYST. AFTER THAT, PATIENT WAS ON FOLLOW-UP." "IN 2025, ENLARGEMENT OF THE CYST WAS CONFIRMED. THERE WAS NO SYMPTOM OF INFECTIOUS DISEASE. NO DETERIORATION HAS BEEN OBSERVED IN THE PATIENT'S CLINICAL CONDITION. THE SHUNT SYSTEM WAS FUNCTIONING PROPERLY. THE CATHETER REMAIN IMPLANTED SINCE THE PATIENT IS STABLE. THE PATIENT IS ON FOLLOW-UP."
THIS FOLLOW-UP IS TO REQUEST THE CANCELLATION OF THIS REPORT (MFG REPORT NUMBER 3013886523-2025-00081). IS NOT AN INTEGRA PRODUCT. INFORMATION RECEIVED: "WITH ADDITIONAL INFORMATION, IT WAS CONFIRMED THAT THE PRODUCT WAS THE COMPETITOR'S."
A PHYSICIAN REPORTED A HAKIM PERITONEAL CATHETER (ID 823045) AND A VALVE (UNKNOWN VALVE) WERE IMPLANTED DUE TO UNKNOWN REASON VIA VENTRICULO-PERITONEAL (V-P) SHUNT IN 2011 WITH UNKNOWN SETTING. THE PERITONAL CATHETER FELL OFF, AND A REVISION SURGERY WAS PERFORM IN 2016. SINCE 2020, RETAINED EXUDATE (APPROXIMATELY 120CC) AND CYST IN THE ABDOMEN WAS OBSERVED. THE CYST HAS ENLARGED TO 13 CM IN DIAMETER. SAMPLE TEST AND CONTRAST IMAGING ON CATHETER HAVE NOT BEEN PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1256984 | HAKIM PERITON CATH,120CM | STANDARD CATHETERS | JXG | INTEGRA LIFESCIENCES MANSFIELD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Unknown | Other |