MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-04 for 1910 POP'N COUNT 31142394 manufactured by Covidien.
[132099245]
The customer reported that the prescott va was trialing a product that resulted in a nurse being stuck with a used needle. Additional information received from the customer states: the nurse who was trialing the product placed the used needle into the needle counter. It was a fine needle, not a large bore needle. She closed the lid, without resistance when closing, and locked the side with the slide lock. When she picked up the needle counter to place it into the sharps container, she was stuck with the used needle, which had punctured through the bottom of the plastic needle counter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2019-02071 |
| MDR Report Key | 8217855 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-04 |
| Date of Report | 2019-04-09 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-04 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD IND |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1910 POP'N COUNT |
| Generic Name | NEEDLE, SUTURING, DISPOSABLE |
| Product Code | GAB |
| Date Received | 2019-01-04 |
| Model Number | 31142394 |
| Catalog Number | 31142394 |
| Lot Number | 1814107564 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-04 |