MAUDE Adverse Event Report: RAYNHAM BULK SURG PAT 1 X 1; OEM PATTIES & STRIPS

Catalog Number 245407

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

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.Device 2of 2 please see medwatch 1226348-2019-00578.

Event Description

It was reported that product #245407 neurological sponge cottonoid® radiopaque was not x-ray detectable.This is the second complaint of two from the same facility but separate cases.

Manufacturer Narrative

Complaint sample was not returned to codman 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.Between 05nov2019 and 30jun2020, 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 (b)(4) 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 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6), director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: BULK SURG PAT 1 X 1
• Type of Device: OEM PATTIES & STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10276511
• MDR Text Key: 204000349
• Report Number: 1226348-2019-00577
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 245407
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1