MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LATEX-FREE O-RINGS 100PK FOR 28-154A, 28-154B LIG; M17 - RECTAL

Catalog Number 28-155

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.(b)(4).

Event Description

Sus voluntary event report foi for manufacturers (mw5092730) was received on 24feb2020 with the following information: a nurse reported that the 28-155 latex-free o-rings 100pk for 28-154a, 28-154b lig had no instructions for use available as per the manufacturer.Product labeled non-sterile however, the manufacturer sent certification letter stating product was sterilized.Additional information has been requested.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h6, h10 device identifier: (b)(4) per the reporter, product was labelled as "non sterile" and not for re-use.Global product label indicates that this is the correct labeling for the product.Per the event description, the labeling was correct.No product was returned for evaluation.No manufacturing, workmanship, or material deficiency has been identified.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 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 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: LATEX-FREE O-RINGS 100PK FOR 28-154A, 28-154B LIG
• Type of Device: M17 - RECTAL
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10279219
• MDR Text Key: 199648326
• Report Number: 2523190-2020-00026
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 28-155
• Device Lot Number: 208372
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1