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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER Back to Search Results
Catalog Number 823074
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 12/06/2021
Event Type  Injury  
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 Description
1 of 2 reports. Other mfg report number: 3013886523-2021-00564. A physician reported a certas valve was implanted via l-p shunt on (b)(6) 2021 with unknown setting. The valve was used with 823074 and the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj). Shunt dysfunction occurred (unknown failure) and the valve and bactiseal peritoneal catheter were removed and replaced on (b)(6) 2021. A large amount of blood was found in the explanted valve. It is unknown if the patient experienced any signs and symptoms due to valve failure.
 
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Brand NameBACTISEAL PERITONEAL CATHETER
Type of DeviceBACTISEAL PERITONEAL 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 Key13079017
MDR Text Key282726102
Report Number3013886523-2021-00565
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 Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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