MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-02-21 for PENCAN? 333871 manufactured by B. Braun Medical Inc..
[67945565]
(b)(4). The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available.
Patient Sequence No: 1, Text Type: N, H10
[67945566]
As reported by user facility: the spinal needle broke off into the patient. Patient had to undergo additional surgery to retrieve the broken off piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2017-00022 |
| MDR Report Key | 6345642 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-01-25 |
| Device Manufacturer Date | 2016-09-14 |
| Date Added to Maude | 2017-02-21 |
| 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 | MS. BRIDSEIDA MELENDEZ |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN? |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-02-21 |
| Model Number | 333871 |
| Catalog Number | 333871 |
| Lot Number | 0061517708 |
| Device Expiration Date | 2018-04-30 |
| 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 | 2017-02-21 |