MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-08-15 for CAP BOUFFANT SPUNBONDED BLUE 3274 manufactured by Cardinal Health.
[19360424]
Customer reports that there was a needle embedded in the cap, and they put the cap on the patient without knowing. The patient then received multiple lacerations as a result of it being on their head. The area was washed and a bandage applied. A needle stick screen was done and reported to be negative.
Patient Sequence No: 1, Text Type: D, B5
[19473183]
The customer did not provide the sample or the lot number, but did provide a photo of the needle. Without the lot number or sample, we were not able to confirm the reported incident. Historical trending was done. A review of the photo of the needle (provided by the customer) suggested the reported needle was a medical needle. These needles were not used during manufacturing, and would not have originated from our manufacturing facility for the bouffant cap. We will continue to monitor for trends of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2012-00030 |
| MDR Report Key | 2699856 |
| Report Source | 05,07 |
| Date Received | 2012-08-15 |
| Date of Report | 2012-08-15 |
| Date of Event | 2012-07-06 |
| Date Mfgr Received | 2012-07-20 |
| Date Added to Maude | 2012-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAP BOUFFANT SPUNBONDED BLUE |
| Generic Name | CAP, SURGICAL |
| Product Code | FYF |
| Date Received | 2012-08-15 |
| Catalog Number | 3274 |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-15 |