MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for AFFIRM 446255 manufactured by Bd.
[59513081]
Patient Sequence No: 1, Text Type: N, H10
[59513082]
I was assisting my provider in collection of an affirm vpiii. I open the package and "broke the ampule" to put the drops in the swab tube, i felt a sharp poke on my index finger and noticed a slit in my glove. The ampule had a piece of glass sticking out of the side and it had cut my finger. This was the first piece of equipment i had handled and luckily, i had not had any contact with the patient or with any of the other collection swabs prior to this. There was no risk of exposure with this incident, but there could have been. Manufacturer response for bd vplll ambient temperature transport system, (brand not provided) (per site reporter): it's a known and rare problem. Sent a device at no charge to use to break ampule.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6089508 |
| MDR Report Key | 6089508 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-06-16 |
| Report Date | 2016-06-21 |
| Date Reported to FDA | 2016-06-21 |
| Date Reported to Mfgr | 2016-06-21 |
| Date Added to Maude | 2016-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | AFFIRM |
| Generic Name | DEVICE, SPECIMEN COLLECTION |
| Product Code | LIO |
| Date Received | 2016-11-09 |
| Catalog Number | 446255 |
| Lot Number | 5005510 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | 5859 FARINON DR. STE. 200 SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-09 |