MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM; STANDARD CATHETERS

Catalog Number 823045

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Injury (2348); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

3 of 3 reports.Other mfg report numbers: 3013886523-2020-00105, 3013886523-2020-00112.A physician reported the patient had clinical signs of an allergic reaction after the certas valve implantation.Therefore, the shunt system was removed in (b)(6) 2020.The valve was connected to hakim ventricular catheter (product#823041/lot#unk) and hakim abdominal catheter (product#823045/lot#unk).

Manufacturer Narrative

Gtin: (b)(4).The hakim catheter was not returned for evaluation (discarded by hospital) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.The potential cause(s) of failure for ¿allergic reaction¿ could be due to ¿inadequate packaging configuration".

Event Description

N/a.

• Brand Name: HAKIM PERITON CATH,120CM
• Type of Device: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10550689
• MDR Text Key: 207510715
• Report Number: 3013886523-2020-00113
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K944222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1