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 2018-11-19 for PENCAN N/A 4502027 manufactured by B. Braun Melsungen Ag.
[128416008]
(b)(4). Investigation was based on the complaint description and returned sample. 1 piece of pencan was returned in opened packaging. Visually inspected the returned sample, no dented or crack was noticed on the protective cap. Pencan needle was inspected under smart scope and jagged end was found at the broken point of pencan needle. The defect caused by packing machine can be ruled out. Reviewed process card, no abnormalities was found during this packing period. 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
[128416029]
As reported by the user facility ((b)(4)): spinal needle broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00249 |
| MDR Report Key | 8084409 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-19 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-10-23 |
| Date Facility Aware | 2018-11-19 |
| Report Date | 2018-01-02 |
| Date Reported to FDA | 2018-01-02 |
| Date Reported to Mfgr | 2018-01-02 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2018-03-21 |
| Date Added to Maude | 2018-11-19 |
| 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 PA 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 | 2018-11-19 |
| Returned To Mfg | 2018-11-09 |
| Model Number | N/A |
| Catalog Number | 4502027 |
| Lot Number | 18C21G8F03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-19 |