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 2019-03-18 for PERIFIX SOFT TIP N/A PCK-Y2000J manufactured by B. Braun Melsungen Ag.
[139055635]
(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 sold in the united sates by b. Braun medical, inc. Visual inspection: the tip of catheter was broken off. The broken tip side was not returned. In the vicinity of the torn area, the interval between markings was wide. Therefore the catheter was stretched. The cross section of the catheter had marks that something had rubbed. This cross section was similar to the shape that would come when pulled back at the time of the procedure. Dimension check: outer diameter: standard: 0. 80mm - 0. 88mm result: end of catheter from 50mm: 0. 8604mm, end of catheter from 100mm: 0. 8593mm all pass. Outer diameter was not stretched. Functional test: catheter breaking strength test object: tensile strength of catheter we tested using the end of the catheter. Standard: 13n or more. Result: pass. Justification: this complaint is not confirmed. Review of manufacturing records: no abnormality was found. Note: this report is being filed as both a product problem and an adverse event due to the fact that the tip of the catheter may have remained in the patient. No intervention was done, and currently there was no serious injury to the patient reported, so this report has been classified only as a malfunction.
Patient Sequence No: 1, Text Type: N, H10
[139055636]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): catheter broken. Fragments have remained in the patient's body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2019-00072 |
| MDR Report Key | 8427973 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-02-18 |
| Date Facility Aware | 2019-03-18 |
| Report Date | 2019-03-18 |
| Date Reported to FDA | 2019-03-18 |
| Date Reported to Mfgr | 2019-03-18 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-18 |
| 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 | 2019-03-18 |
| Returned To Mfg | 2019-03-04 |
| Model Number | N/A |
| Catalog Number | PCK-Y2000J |
| Lot Number | 18L06H82YL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Other | 2019-03-18 |