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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT
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INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT Back to Search Results
Catalog Number 823072
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
1 of 2 reports.Other mfg report number: 3013886523-2020-00030.A facility reported the bactiseal catheter kit was expired when received.No patient contact/injury reported and the event did not led to surgical delay.
 
Manufacturer Narrative
The catheter was returned for evaluation.Device history record (dhr) - lot number: 3986055, conformed to the specifications when released to stock.Failure analysis - the product was not expired at time of shipment.The product can ship with an expiration period of 60 days left.The product expired 31 aug 2020 which was still above the 60 days when the order was shipped.Root cause cannot be determined as product was not expired.
 
Event Description
N/a.
 
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Brand Name
CODMAN BACTISEAL CATHETER KIT
Type of Device
BACTISEAL CATHETER KIT
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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MDR Report Key10380123
MDR Text Key202953575
Report Number3013886523-2020-00031
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K102589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Catalogue Number823072
Device Lot Number3986055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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