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 2018-08-22 for PERIFIX SOFT TIP N/A 4514017C manufactured by B. Braun Melsungen Ag.
[118233556]
(b)(4). 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: one optical unused perifix catheter and one used perifix catheter connected with a perifix catheter connector and a perifix filter out of a perifix one 401 filterset without packaging. The samples are connected with an extension line. The provided perifix catheters were subjected to a visual examination. As-received condition the used catheter is cut off, at the second catheter we detected no damages. Afterwards the length of the cut off perifix catheter was measured according to drawing. Nominal: 1010 +/- 7. 5 mm. Actual: 990 mm. The shorn off part including the catheter tip was not handed over. Such damages may occur when the catheter has been withdrawn against the cannula bevel and shearing the catheter tip. Instructions for use: "never pull the catheter through the needle as it may otherwise shear off. " the catheters are subjected to a 100 % examination during manufacture, therefore, mechanical damage and manufacturing faults can be excluded. We assume a problem during application. This complaint is not confirmed. 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
[118233557]
As reported by the user facility ((b)(4)): catheter was broken off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00171 |
| MDR Report Key | 7805321 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-22 |
| Date of Report | 2018-12-05 |
| Date Facility Aware | 2018-08-22 |
| Report Date | 2018-12-05 |
| Date Reported to FDA | 2018-12-05 |
| Date Reported to Mfgr | 2018-12-05 |
| Date Mfgr Received | 2018-07-27 |
| Device Manufacturer Date | 2018-02-12 |
| Date Added to Maude | 2018-08-22 |
| 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 | PERIFIX SOFT TIP |
| Generic Name | EPIDURAL CATHETER |
| Product Code | DQR |
| Date Received | 2018-08-22 |
| Returned To Mfg | 2018-08-03 |
| Model Number | N/A |
| Catalog Number | 4514017C |
| Lot Number | 18B12A8701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 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 | 2018-08-22 |