MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 3X3 -200; SURGICAL PATTIES

Catalog Number 801409

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

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

A facility reported an incorrect count in the packaging of surgical patties.Staff reportedly opened the surgical patties 3¿ x 3¿ and noted an extra ¿one blank white sheet¿ in addition to the labeled 10 available in the package.The package was reportedly taken outside the room before the planned operation.The product was not in contact with the patient and the event led to surgical delay (unknown for how long).No patient injuries were reported.

Event Description

N/a.

Manufacturer Narrative

Udi - (b)(4).The surgical patties were not returned for evaluation (no confirmation from customer); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Despite the product not being returned, the fmea was reviewed for possible root causes of the reported failure.For a complaint regarding incorrect count, the fmea refers to likely root causes to be either an error in transfer in the machine¿s pneumatic cylinder, or operator error during inspection.A corrective action has been opened to further investigate failures for the patties/strips product family which relate to discoloration, incorrect count, string issues, and x-ray detectability.

• Brand Name: SURG PAT XRAY 3X3 -200
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• MDR Report Key: 10654424
• MDR Text Key: 210595637
• Report Number: 3014334038-2020-00061
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801409
• Device Lot Number: J4044G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1