MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for STERILE CIRCUMCISION TRAY 10-0078F manufactured by Cardinal Health 200, Llc.
[87584035]
Patient Sequence No: 1, Text Type: N, H10
[87584036]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6897750 |
| MDR Report Key | 6897750 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-03 |
| Report Date | 2017-08-31 |
| Date Reported to FDA | 2017-08-31 |
| Date Reported to Mfgr | 2017-08-31 |
| Date Added to Maude | 2017-09-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE CIRCUMCISION TRAY |
| Generic Name | CIRCUMCISION TRAY |
| Product Code | OHG |
| Date Received | 2017-09-27 |
| Catalog Number | 10-0078F |
| Lot Number | 441859 |
| Device Expiration Date | 2018-12-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1500 WAUKEGAN RD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-27 |