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 2020-02-20 for PERIFIX? PCK-732J-2 manufactured by B. Braun Melsungen Ag.
[183159138]
(b)(4). We received one perifix kit. The following investigations were conducted: visual inspection: [catheter visual inspection] the catheter within the kit was torn at 952mm from the end of the catheter. Closer inspection of the torn end of the catheter displayed scratches. The scratches were similar to scratches caused by a tear from catheter pull-out application error. [perican bulk visual inspection] no abnormalities found. No abnormalities/burr/protrusions found from the needle tip. Device history review: no abnormalities found from reviewing the batch records for batch no. 19b27a8601. Summary and assessment: we assume a problem during application process. Based on the conducted investigations the samples are within the specification. Therefore the complaint is considered as not confirmed. Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b. Braun medical, inc.
Patient Sequence No: 1, Text Type: N, H10
[183159139]
As reported by the user facility ((b)(4)): catheter damaged. Catheter was torn apart. The residue remains in the patient's body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2020-00037 |
| MDR Report Key | 9735009 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-20 |
| 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, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIFIX? |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-02-20 |
| Returned To Mfg | 2020-02-07 |
| Catalog Number | PCK-732J-2 |
| Lot Number | 19L12H81YM |
| 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, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |