MAUDE Adverse Event Report: MEDLINE INDUSTRIES TOTAL KNEE PACK - LF; CUSTOM SURGICAL PACK

Catalog Number CMPJ08240A

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 03/05/2018

Event Type  malfunction  

Event Description

During setup, a black fiber was found embedded in one of the packs of sponges from a total knee custom pack.The contaminated item was removed, and this did not reach the patient.Per site reporter: the medline field representative was notified and reported event to medline quality team.

• Brand Name: TOTAL KNEE PACK - LF
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline pl.; mundelein IL 60060
• MDR Report Key: 7337337
• MDR Text Key: 102343717
• Report Number: 7337337
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942668915
• UDI-Public: (01)10889942668915
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

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: No Information
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: CMPJ08240A
• Device Lot Number: 18AD1654
• Other Device ID Number: TOTAL KNEE PACK TROY - LF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1