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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PERIT CATH BA SALMON 90CM STANDARD CATHETERS

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INTEGRA LIFESCIENCES SWITZERLAND SAR PERIT CATH BA SALMON 90CM STANDARD CATHETERS Back to Search Results
Catalog Number 821684
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Cerebrospinal Fluid Leakage (1772); Injury (2348)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
Unique device identifier (udi): (b)(4). The catheter was not returned for evaluation (per customer; is not available) 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.
 
Event Description
2 of 2 reports. Other mfg report number: 3013886523-2020-00192. A facility reported the codman certas valve with sg (model 828804 )and a plain silicon catheter (model refs 823041 and 821684) were implanted to a (b)(6) year old male patient on october 19. Three days post op, the surgeon noticed csf leaking from the incision site. On october 22, the surgeon took the patient back to the or and the certas plus valve and peritoneal catheter were revised (catheter model ref 821684 holter distal peritoneal catheter). It was noted that the valve had split down the middle and the peritoneal catheter had dislodged at the valve connection point. The siphon guard had completely dislodged from the valve. The patient did not experience a fall or hit to the head post op and the surgeon stated that they did not bend the valve on insertion. The ventricular catheter was not revised (model ref 823041 hakim ventricular catheter).
 
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Brand NamePERIT CATH BA SALMON 90CM
Type of DeviceSTANDARD CATHETERS
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
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key10841097
MDR Text Key216334521
Report Number3013886523-2020-00193
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number821684
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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