MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-21 for PENCAN N/A 4502043 manufactured by B. Braun Melsungen Ag.
[67890594]
(b)(4). We have informed our manufacturer accordingly. A follow-up report will be provided after the statement is available.
Patient Sequence No: 1, Text Type: N, H10
[67890595]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): needle broke - surgery.
Patient Sequence No: 1, Text Type: D, B5
[112351107]
(b)(4). No sample was returned. Review of manufacturing records no abnormality was found. The 2 stiffness test (retention sample) result: within specification. The root cause for needle broken off was not determined. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610825-2017-00035 |
| MDR Report Key | 6347307 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-21 |
| Date of Report | 2017-01-27 |
| Date of Event | 2017-01-10 |
| Report Date | 2017-06-26 |
| Date Reported to FDA | 2017-06-26 |
| Date Reported to Mfgr | 2017-06-26 |
| Date Mfgr Received | 2017-01-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN |
| Generic Name | SPINAL NEEDLE |
| Product Code | MIA |
| Date Received | 2017-02-21 |
| Model Number | N/A |
| Catalog Number | 4502043 |
| Lot Number | UNKNOWN |
| 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 MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-21 |