MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for PARACERVICAL PUD TRAY CONTROL SYRINGE 4540A manufactured by Carefusion, Inc.
[131895770]
(b)(4) a follow up submission will be submitted post investigation or if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[131895771]
Event date unknown: the female patient was having some? Repair work? Done after the delivery of her child in the birthing center at the hospital. Upon insertion of the 4540a syringe the needle broke inside the patient. The patient was then moved to the or for further exploration, xray and ultrasound. The broken tip was never found. The patient has had multiple return trips to the hsp for xray, ultrasound, dr visits, has continued pain, and mental trauma from this adverse event. The patient has had pain medication and antibiotics as a result as well. (b)(6) 2018: customer response: lot number is not available, procedure was not performed under ct guidance, broken needle occurred immediately after insertion, this was patient's first pudendal block, patient did indeed have exploratory surgery attempting to locate retained product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680904-2018-00032 |
| MDR Report Key | 8208684 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-02-20 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2019-01-02 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARACERVICAL PUD TRAY CONTROL SYRINGE |
| Generic Name | PARACERVICAL NEEDLE |
| Product Code | HEE |
| Date Received | 2019-01-02 |
| Catalog Number | 4540A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | ZONA FRANCA LAS AMERICAS SANTO DOMINGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-01-02 |