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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM STANDARD CATHETERS

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INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM STANDARD CATHETERS Back to Search Results
Catalog Number 823045
Device Problem Infusion or Flow Problem (2964)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 11/07/2020
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 3 reports. Other mfg report numbers: 3013886523-2020-00274; 3013886523-2020-00275. A physician reported the hakim peritoneal catheter was implanted, and connected to a certas valve (product id:828804, lot#: 4739012) and bactiseal (product id: 823073, lot#: 4397529) to the patient via v-p shunt on (b)(6) 2020 with an unknown setting. However, infection was observed at the peritoneal site and furthermore, csf flow to the peritoneal side could not be confirmed. Therefore, the valve was replaced to a new one on an unknown date. Type of infection/organism was unknown. Type of treatment or medication given for the infection was unknown.
 
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Brand NameHAKIM PERITON CATH,120CM
Type of DeviceSTANDARD CATHETERS
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key11073575
MDR Text Key224038331
Report Number3013886523-2020-00273
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K944222
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823045
Device Lot Number4138406
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
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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