MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-12-07 for PENCAN N/A 4454820 manufactured by B. Braun Melsungen Ag.
[94119317]
(b)(4). No sample has been returned for investigation. The batch record could not be reviewed since the lot number is not known. Without the actual sample or lot number, a thorough investigation can not be performed. All available information has been forwarded to the actual manufacturer. Note: this report is being filed for the product problem. A second report was filed for the same event, under mfr report number 9610825-2017-00240, to capture the adverse event that required surgical intervention.
Patient Sequence No: 1, Text Type: N, H10
[94119318]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): broken cannula. About 3 cm left inside of patient, which required an extra operation to remove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2017-00241 |
| MDR Report Key | 7095893 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-07 |
| Date Facility Aware | 2017-12-07 |
| Report Date | 2017-12-07 |
| Date Reported to FDA | 2017-12-07 |
| Date Reported to Mfgr | 2017-12-07 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-12-07 |
| 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 | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| 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 | 2017-12-07 |
| Model Number | N/A |
| Catalog Number | 4454820 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-12-07 |