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 2018-09-11 for PENCAN N/A 4556666 manufactured by B. Braun Melsungen Ag.
[119821527]
(b)(4). Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are used in products that are sold in the united states by b. Braun medical, inc. " we received: no samples, pictures of an espocan set m. Pencan 0. 42 x 127. 5 mm. The pictures show a used catheter. The catheter is cut off. Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off. Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off. " therefore we assume that the defect occurred during the application process (wrong handling). The complaint is assessed to be not confirmed. We exclude a manufacturing fault since the catheters are taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed. We have informed our manufacturer accordingly and requested a batch review. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[119821528]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4): catheter broken & remained in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00191 |
| MDR Report Key | 7864160 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-10 |
| Date Facility Aware | 2018-09-11 |
| Report Date | 2018-09-14 |
| Date Reported to FDA | 2018-09-14 |
| Date Reported to Mfgr | 2018-09-14 |
| Date Mfgr Received | 2018-08-16 |
| Device Manufacturer Date | 2018-02-14 |
| Date Added to Maude | 2018-09-11 |
| 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 | 2018-09-11 |
| Model Number | N/A |
| Catalog Number | 4556666 |
| Lot Number | 18B14G8F01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| 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 | 2018-09-11 |