MAUDE Adverse Event Report: MEDLINE INDUSTRIES TOTAL SHOULDER PACK; CUSTOM SURGICAL PACK

Catalog Number CMPJ08236

Device Problems Break (1069); Device Contamination With Biological Material (2908)

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

Event Date 03/02/2018

Event Type  malfunction  

Event Description

The patient was in the room and intubated, when a scrub tech noticed a hair on a lap sponge from the custom pack prior to incision.The entire room, including instruments was broken down.A second custom pack was opened and a gown was found to have a bug on it prior to touching any instruments.Only the pack was replaced a second time.The contaminated packs were not saved by staff due to time constraints of having multiple set ups after the patient was already intubated.Per site reporter: the manufacturer's field representative was notified, and has reported this to medline's quality team.

• Brand Name: TOTAL SHOULDER PACK
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline pl.; mundelein IL 60060
• MDR Report Key: 7337336
• MDR Text Key: 102343648
• Report Number: 7337336
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942549832
• UDI-Public: (01)10889942549832
• 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: 07/31/2019
• Device Catalogue Number: CMPJ08236
• Device Lot Number: 17JD2140
• Was Device Available for Evaluation?: No
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 84