MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DYNJ CUSTOM PACK - TR - SPINAL PACK - LF; CUSTOM SURGICAL PACK

Catalog Number DYNJ55493A

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Event Description

During procedure set up, a hole was discovered in the double basin cover.A new pack was opened to use during the procedure and no harm came to the patient.The pack was saved for the medline representative.All contaminated custom pack samples are being collected for investigation by medline field rep.

• Brand Name: DYNJ CUSTOM PACK - TR - SPINAL PACK - LF
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 7305230
• MDR Text Key: 101308435
• Report Number: 7305230
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942670062
• UDI-Public: (01)10889942670062
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: DYNJ55493A
• Device Lot Number: 17LD0166
• 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: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2018
• 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