MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV UNITIZED

Catalog Number 823114

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that on (b)(6) 2019, the hakim valve ruptured during the lubrication of the system in the subcutaneous path.The rupture was at the proximal part, at the junction of the valve with the peritoneal catheter.This generated a few minutes surgical delay and more anesthesia time for the patient, which was a child.

Manufacturer Narrative

Unique device identifier (udi)- (b)(4).The valve was returned for evaluation: device history record (dhr)- lot 3477556 showed an nr-report when released to stock on the 26th march 2019.The nr report issues had no link to this complaint.Failure analysis- the valve was visually inspected; the distal unitized part of the valve with a part of the catheter was not returned for investigation.The silicone housing was visually inspected, and shows signs of the silicone being torn/cut from valve.The root cause for the cut/tear in the silicone housing is probably due to a sharp or pointed object coming into contact with the silicone housing, as noted in the instruction for use (ifu) silicone has a low cut/tear resistance.

Manufacturer Narrative

Sample was not received for evaluation.Dhr- lot 3477556, showed an nr-report when released to stock on the (b)(6)2019.The nr report issue had no link to this complaint.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.Between (b)(6)2019 and (b)(6)2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period (b)(6)2019 through (b)(6)2020.Integra lifesciences contacted donna engleman, director of regulatory programs, office of product evaluation and quality and michelle rios, assistant director, mdr team, office of product evaluation and quality on (b)(6)2020 to report these issues regarding mdr reports.

Event Description

N/a.

• Brand Name: MICRO CHPV UNITIZED
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10292454
• MDR Text Key: 203306755
• Report Number: 1226348-2020-00420
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 823114
• Device Lot Number: 3477556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1