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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 Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2020
Event Type  malfunction  
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
2 of 2 reports.Other mfg report number: 3013886523-2020-00245.A facility reported that on (b)(6) 2020, the bactiseal catheter was not shipped and the surgery was cancelled when the patient was already "on the table".
 
Manufacturer Narrative
Unique device identification (udi): (b)(4).The bactiseal catheter was not shipped to customer and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.
 
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Brand Name
BACTISEAL PERITONEAL CATHETER
Type of Device
BACTISEAL PERITONEAL CATHETER
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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MDR Report Key11042086
MDR Text Key230316592
Report Number3013886523-2020-00246
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 company representative,user f
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number823074
Was Device Available for Evaluation? No
Date Manufacturer Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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