MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC STERILE CIRCUMCISION TRAY

Catalog Number 10-0078F

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Event Description

Hemostats (listed in sterile circumcision tray as "3 pk forcep halstead mosquito") do not hold as needed.Clinician reported the devices "popped off" during use.No patient injury occurred, but proper holding is essential during a circumcision.Staff reported 4 occurrences in 1 day with same lot number.This lot was removed from stock, manufacturer was called to report this concern, and we requested priority shipment of trays with a different lot number.In the meantime until new trays were received, individual prepackaged sterile disposable mosquito forceps were stocked in the event kits with a different lot number had similar issues.The forceps that were reported to "pop off" and not hold were not preserved; no samples available.Manufacturer response for halstead mosquito forceps, halstead mosquito forceps in sterile circumcision tray (per site reporter).No response received.

• Brand Name: STERILE CIRCUMCISION TRAY
• Type of Device: CIRCUMCISION TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 6897750
• MDR Text Key: 87584036
• Report Number: 6897750
• Device Sequence Number: 1
• Product Code: OHG
• 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: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: 10-0078F
• Device Lot Number: 441859
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2017
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2017
• 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