MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC CMPJ CUSTOM PACK - ADD ON-EASTON SPINE PACK; CUSTOM SURGICAL PACK

Catalog Number CMPJ08233

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Event Description

A medline pack was found to have a large piece of dirty tape.The room was torn down and another set up was obtained.No harm came to the patient and the procedure was completed as planned.Manufacturer response for custom surgical pack, cmpj custom pack - add on-(b)(4) spine pack (per site reporter).Medline is investigating contaminated custom packs.Any further information received will be shared with medsun as it becomes available.

• Brand Name: CMPJ CUSTOM PACK - ADD ON-EASTON SPINE PACK
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; 1 medline place; mundelein IL 60060
• MDR Report Key: 7285314
• MDR Text Key: 100643305
• Report Number: 7285314
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942550180
• UDI-Public: (01)10889942550180
• 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: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: CMPJ08233
• Device Lot Number: 17ED2771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 76