MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VENT RES TR RICKHAM ST BA; RESERVOIRS

Model Number	821621
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A facility reported "after insertion of the proximal catheter and subsequent release of the rickham reservoir, it dislocated from its metal attachment, leaving the proximal catheter attached only to the metal mount and no reservoir.As a result, the proximal catheter had to be removed, a new rickham attached and the catheter replaced." additional information received: the proximal catheter was connected to the rickham and a ligature was applied as usual.It was implanted as usual: advancement of the proximal catheter with the rickham reservoir attached.The patient has a pronounced stitch canal bleeding whereas this is probably not due to the manipulation to exchange the rickham reservoir.For replacement, the catheter was simply pulled back a bit, the defective reservoir was removed after loosening the ligature, a new reservoir was attached along with a new ligature.Estimated around 10-15 minutes.A new reservoir had to be retrieved and the two reservoirs replaced.
Additional Manufacturer Narrative
Complaint sample was returned for evaluation: dhr - lot 6267053, conformed to the specifications when released to stock.Failure analysis - the rickham reservoir was returned in 2 parts and was visually inspected; no defects were noted with the silicone cap or the metal connector, it looks like they have been separated during handling.Root cause - the possible root cause for the issue reported by the customer could be due to atypical force, possible when connecting the catheter, at the time of investigation no defects (cut/tear) were noted with the rickham reservoir, only that the 2 parts were separated when returned.
Event or Problem Description
N/a.

• Brand Name: VENT RES TR RICKHAM ST BA
• Common Device Name: RESERVOIRS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15148574
• Report Number: 3013886523-2022-00360
• Device Sequence Number: 5671055
• Product Code: JXG
• UDI-Device Identifier: 10381780517771
• UDI-Public: (01)10381780517771(17)270430(10)6267053
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 821621
• Device Catalogue Number: 821621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown