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

Model Number	821735
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported two missing parts (female luer lock and luer lock connector cap) in the kit (eds3 clear vent cath).Without these parts, catheter could not be connected to monitoring or to system to collect csf.The procedure was completed with a replacement product.No patient injury reported; however, the event led to more than one hour surgical delay.
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
N/a.
Additional Manufacturer Narrative
The evd catheter was returned for evaluation: - failure analysis - the device was returned in open box, but unopened pouch.The device was checked with the packaging drawing all parts correct.The complaint is unconfirmed.Root cause - the root cause is due to user's error, not opening the pouch to find all parts are correct, or maybe wrong device taken from hospital stock.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.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.
Event or Problem Description
N/a.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15363854
• Report Number: 3013886523-2022-00408
• Device Sequence Number: 6889901
• Product Code: JXG
• UDI-Device Identifier: 10381780518372
• UDI-Public: (01)10381780518372(17)270331(10)6331400
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2023

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 Model Number: 821735
• Device Catalogue Number: 821735
• Device Lot Number: 6331400
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 05/11/2023; 11/27/2023
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 06/05/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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