MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC DYNJ CUSTOM PACK - SEPT-RHINOPLASTY-TROY PK-LF; CUSTOM SURGICAL PACK

Model Number TROY PK-LF

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

During case set up, black particles were found on the underside of the basin wrap and on the drapes in the septo-rhinoplasty troy pack from medline.Materials were removed from the field and a new set up was obtained.No harm came to the patient and the procedure was completed as planned with the new set up.Manufacturer response for surgical pack, dynj pack - sept-rhinoplasty-troy pk-lf (per site reporter).Medline is investigating pack contamination currently.We will update medsun with information as it becomes available to us.

Event Description

During case set up, black particles were found on the underside of the basin wrap and on the drapes in the septo-rhinoplasty troy pack from medline.Materials were removed from the field and a new set up was obtained.No harm came to the patient and the procedure was completed as planned with the new set up.Manufacturer response for surgical pack, dynj pack - sept-rhinoplasty-troy pk-lf (per site reporter).Medline is investigating pack contamination currently.We will update medsun with information as it becomes available to u.S.

• Brand Name: DYNJ CUSTOM PACK - SEPT-RHINOPLASTY-TROY PK-LF
• Type of Device: CUSTOM SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; 1 medline place; mundelein IL 60060
• MDR Report Key: 7285376
• MDR Text Key: 100643208
• Report Number: 7285376
• Device Sequence Number: 1
• Product Code: MMO
• 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,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TROY PK-LF
• Device Catalogue Number: DYNJ0396069F
• Device Lot Number: 16KD0473
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 59