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 2018-10-11 for PENCAN N/A 4502027-01 manufactured by B. Braun Melsungen Ag.
[124677775]
(b)(4). This report has been identified as event two of b. Braun (b)(4) internal report # (b)(4). No sample has been returned for investigation. If the sample and/or additional pertinent information becomes available, a follow up report will be submitted. Retention sample: pencan 27gx3 1/2 (0. 4x88mm)-eu, mat no. 4502027-01xx, batch no. 18c01h8b23. Functional test: stiffness test, spec: max 0. 65mm, retention sample: 0. 346mm, span: 7. 5mm, weight: 5. 5n. Result: pass. A review of the batch and manufacturing records revealed no abnormalities or nonconformities.
Patient Sequence No: 1, Text Type: N, H10
[124677776]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): event 2. Pencan broken inside patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00218 |
| MDR Report Key | 7957094 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-11 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-09-10 |
| Date Facility Aware | 2018-10-09 |
| Report Date | 2019-01-03 |
| Date Reported to FDA | 2019-01-03 |
| Date Reported to Mfgr | 2019-01-03 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2018-10-11 |
| 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 | 2018-10-11 |
| Returned To Mfg | 2018-10-18 |
| Model Number | N/A |
| Catalog Number | 4502027-01 |
| Lot Number | 18C01H8B23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 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 | 2018-10-11 |