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 2017-06-28 for PENCAN N/A 4502051-13 manufactured by B. Braun Melsungen Ag.
[78595800]
(b)(4). We received one pencan 27gx3 1/2" (88mm) m. Fk-eu/ap/sa in original packaging. The returned sample was taken to a visual inspection. Damages or manufacturing faults especially at the raw cannula were not detected on the returned sample. In addition, the pencan cannula was taken to a manual function test in combination with the introducer needle. The pencan cannula could be pushed through the introducer needle without any resistance. Withdrawing was also possible without any problems. Function faults were not detected. Furthermore, the outside diameter of the pencan cannula was measured according to the drawing. Nominal: 0. 42 +0. 01/-0. 00 mm, actual: 0. 42 mm. The measured outside diameter of the pencan cannula is within the specification. In addition, the pencan cannula was taken to a cannula stiffness test according to the test plan. Nominal: test force = 5. 5 n; bending max. = 0. 55 mm, actual: bending = 0. 282 mm, the measured value is within the specification. The returned sample is in accordance with the specification. A review of the batch and manufacturing records revealed no abnormalities or nonconformities.
Patient Sequence No: 1, Text Type: N, H10
[78595801]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4): cannula detached inside patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2017-00127 |
| MDR Report Key | 6673491 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-05-23 |
| Report Date | 2017-06-28 |
| Date Reported to FDA | 2017-06-28 |
| Date Reported to Mfgr | 2017-06-28 |
| Date Mfgr Received | 2017-06-06 |
| Device Manufacturer Date | 2016-12-23 |
| Date Added to Maude | 2017-06-28 |
| 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 | 200 BOULDER DR. |
| Manufacturer City | BREINIGSVILLE PA 18031 |
| Manufacturer Country | US |
| Manufacturer Postal | 18031 |
| 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 | 2017-06-28 |
| Returned To Mfg | 2017-06-13 |
| Model Number | N/A |
| Catalog Number | 4502051-13 |
| Lot Number | 16N23H8B21 |
| 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 | 2017-06-28 |