MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CUSTOM DYNJ PACK; CUSTOM DYNJ PACKS

Catalog Number DYNJO395959Q

Device Problem Material Frayed (1262)

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

Event Date 09/08/2017

Event Type  malfunction  

Event Description

It was noticed during the case that the lap sponge was fraying.The fraying was first discovered by the surgical tech and the sponge was removed from the field.

• Brand Name: CUSTOM DYNJ PACK
• Type of Device: CUSTOM DYNJ PACKS
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6964628
• MDR Text Key: 89835409
• Report Number: 6964628
• Device Sequence Number: 1
• Product Code: LRO
• 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: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJO395959Q
• Device Lot Number: 17GD0102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2017
• 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: 44 YR
• Patient Weight: 76