MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-04 for CHEMO DISPENSING PIN? manufactured by B. Braun Medical Inc..
[96494325]
(b)(4). The investigation is ongoing at this time. A follow-up report will be submitted when the results of the investigation become available.
Patient Sequence No: 1, Text Type: N, H10
[96494326]
Stopper displacement occurred when the chemo pen was used with the oncology product, bendeka. Limited information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2017-00182 |
| MDR Report Key | 7163627 |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-04 |
| Date Mfgr Received | 2017-12-05 |
| Date Added to Maude | 2018-01-04 |
| 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 | JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHEMO DISPENSING PIN? |
| Generic Name | NEEDLEFREE COLLECTION SYST |
| Product Code | FNY |
| Date Received | 2018-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-04 |