MAUDE Adverse Event Report: CUSTOM TOTAL JOINT PACK CUSTOM TOTAL JOINT PACK

Lot Number 16BK1349

Device Problems Device Damaged Prior to Use (2284); Device Contamination With Biological Material (2908); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Four events in which surgical staff identified hair in medline industries products as they were prepping for surgery, resulting in tearing down the set up and start fresh, delay of surgery.Date of incidents, (b)(6) 2016, hair attached to lap sponge (occurred twice this spring with the following product identifier (b)(4).(b)(6) 2016, black hair found on drapes of custom total joint pack - (b)(6) 2016, hair was found in bottom of c-section pack, (b)(4), expiration date: (b)(6) 2017.Dates of use: 2016.(b)(6) notified medline industries regarding the supply concerns.Initial notification (b)(6) 2016.Repeat notification after each event.

• Brand Name: CUSTOM TOTAL JOINT PACK
• Type of Device: CUSTOM TOTAL JOINT PACK
• Manufacturer (Section D): CUSTOM TOTAL JOINT PACK
• MDR Report Key: 5846078
• MDR Text Key: 51267907
• Report Number: MW5063818
• Device Sequence Number: 2
• Product Code: LRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 16BK1349
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1