MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that after unpacking the device, the physician found that there is white foreign matter on the bactiseal catheter (id 823073).The procedure was completed with a replacement product available.No patient injury reported, and the event did not led to surgical delay.
Additional Manufacturer Narrative
The bactiseal catheter (id 823073) was returned for evaluation.Device history record (dhr) - lot 6756529, conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected, a foreign matter was noted.The complaint was confirmed.The root cause for the issue reported by the customer was possible due to ¿lid wrinkles or creases during manufacturing process post- sealing operations¿.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Common Device Name: BACTISEAL VENTRICULAR CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17007249
• Report Number: 3013886523-2023-00157
• Device Sequence Number: 15026631
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: (01)10381780515623(17)231031(10)6756529
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 823073
• Device Lot Number: 6756529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown