MAUDE Adverse Event Report: MEDLINE INDUSTRIES DYNJ CUSTOM PACK; CUSTOM SURGICAL PACK

Catalog Number DYNJ54802B

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Event Description

During a procedure, the st noticed that the 18x18 from the major pack had frayed.The 18x18s were removed from the sterile field and saved for return.New sponges were introduced, and the procedure was completed as planned with no harm to the patient.No fragments were left in the patient.Per site reporter: this event was reported to the manufacturer sales rep.He will be filing a complaint within medline's system.

• Brand Name: DYNJ CUSTOM PACK
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; 1204 townline rd; mundelein IL 60060
• MDR Report Key: 7147299
• MDR Text Key: 95806617
• Report Number: 7147299
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942670086
• UDI-Public: (01)10889942670086
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJ54802B
• Device Lot Number: 17HD2663
• 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: 12/21/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2017
• 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: 56 YR
• Patient Weight: 68