MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-18 for PENCAN N/A 4502043-13 manufactured by B. Braun Melsungen Ag.
[60360092]
(b)(4). No sample has been returned for investigation. Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event. A follow-up report will be provided after the review of the dhr was done.
Patient Sequence No: 1, Text Type: N, H10
[60360093]
As reported by the user facility ((b)(4)): needle-damaged-broken.
Patient Sequence No: 1, Text Type: D, B5
[66584286]
(b)(4). No sample has been returned for investigation. Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event. Review of manufacturing records: no abnormality was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610825-2016-00801 |
| MDR Report Key | 6113324 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-18 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-10-21 |
| Date Facility Aware | 2016-10-26 |
| Report Date | 2017-02-03 |
| Date Reported to FDA | 2017-02-03 |
| Date Reported to Mfgr | 2017-02-03 |
| Date Mfgr Received | 2016-10-26 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2016-11-18 |
| 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 | DR. LUDWIG SCHUETZ |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, HESSEN 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal | 34212 |
| Manufacturer Phone | 5661712769 |
| 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 | 2016-11-18 |
| Model Number | N/A |
| Catalog Number | 4502043-13 |
| Lot Number | 16E16H8B21 |
| 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 | 2016-11-18 |