MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS3 CLEAR VENT CATH; STANDARD EVD CATHETERS

Catalog Number	821735
Medical Device Problem Codes	Disconnection (1171); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Fever (1858)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
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 a patient had a procedure on (b)(6) 2024 evening to set up an external drainage system: the patient (who had arms and legs restrained) was found without the head bandage and external derivation was out.Part of the catheter had fallen in the bandage and the tube was almost removed.The bandage was full of cerebrospinal fluid and the evd did not drain a lot since the patient came back from the operating room.Medical staff stated: "we don't know why a part of the tube was found in the bandage but it cannot have been ripped off by the patient as the section was clean and straight." the patient had to undergo an emergency scan and a new procedure in operative room for set up a new evd.They noticed patient had fever, treated with prophylactic antibiotic.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Dhr - lot 7282409, conformed to the specifications when released to stock.Failure analysis - the catheter pieces were visually inspected; both ends of the catheter seem to be clean cut.The photo provided by the customer show the catheter in 2 parts.The root cause for the issue reported by the customer, could be due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu silicone has a low cut/tear resistance.

• Brand Name: EDS3 CLEAR VENT CATH
• Common Device Name: STANDARD EVD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19282315
• Report Number: 3013886523-2024-00136
• Device Sequence Number: 15347668
• Product Code: JXG
• UDI-Device Identifier: 10381780518372
• UDI-Public: (01)10381780518372(17)280831(10)7282409
• Combination Product (Y/N): N
• PMA/510(K) Number: K061568
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 821735
• Device Lot Number: 7282409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown