MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 1/2X1 1/2; SURGICAL PATTIES

Model Number 801404

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2021

Event Type  malfunction  

Manufacturer Narrative

Sample was not returned for evaluation; however, a photo was provided and analyzed.Dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - complaint confirmed, 11 patties presented in the photo.The complaint could be verified through failure analysis.Root cause - the complaint was confirmed in the complaint investigation.Per the failure analyst: ¿801404 patties are produced using hybrid equipment which uses and operator to cycle the machine and inspect the patties.The machine produces 10 patties and stacks them for the operator to review.It appears the machine was cycled once and stopped at the first pattie.When the operator reset the machine they did not clear out the patties made then produced a stack on 10 on top of the initial 1.This resulted in 11 patties present.The operator did not properly inspect the stack of 10 for proper count.An operator retraining will be completed to address the issue.¿ a corrective action was implemented to further investigate the issue.

Event Description

A facility reported there were 11 surgical patties in the packet instead of 10.No patient injury reported.It is unknown if the event led to surgical delay.

• Brand Name: SURG PAT XRAY 1/2X1 1/2
• Type of Device: SURGICAL PATTIES
• 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: 12662317
• MDR Text Key: 277383288
• Report Number: 3014334038-2021-00214
• Device Sequence Number: 1
• Product Code: HBA
• UDI-Device Identifier: 10381780515005
• UDI-Public: 10381780515005
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801404
• Device Catalogue Number: 801404
• Device Lot Number: 5542810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1