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 2018-12-13 for PENCAN N/A 4502043-13 manufactured by B. Braun Melsungen Ag.
[130493133]
(b)(4). We received one used pencan 25gx3 1/2" (88mm)m. Fk-eu/ap/sa without packaging and one sample in original closed packaging. The returned samples were taken to a visual examination. The used pencan cannula is broken off approx. 50 mm behind the cannula hub. We detected kinks approx. 60 mm and 70 mm behind the cannula hub. At the tip of the cannula no damages were detected. The structure of the break shows that the cannula was bent before break. At the original packed sample we detected no damages. In addition, the outside diameter of the pencan cannulas were measured according to drawing. Nominal-value: 0. 53 mm +0. 01/-0 mm. Actual-values: used sample = 0. 53 mm. Actual-values: unused sample = 0. 53 mm. The measured values (outside diameters) of the pencan cannulas are within the specification. With regard to the used sample we assume problem during application. Review of manufacturing records: any abnormality was not found. Stiffness test; batch no. 18c20h8b21 - retention sample - standard: max 0. 43mm, span 10. 0mm, load 7n, result: 0. 350mm - pass. This complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[130493134]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): needle tip is broken off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00264 |
| MDR Report Key | 8160545 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-15 |
| Date Facility Aware | 2018-12-13 |
| Report Date | 2018-12-13 |
| Date Reported to FDA | 2018-12-13 |
| Date Reported to Mfgr | 2018-12-13 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2018-03-20 |
| Date Added to Maude | 2018-12-13 |
| 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 | 2018-12-13 |
| Returned To Mfg | 2018-12-04 |
| Model Number | N/A |
| Catalog Number | 4502043-13 |
| Lot Number | 18C20H8B21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 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 | 2018-12-13 |