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 2018-08-31 for PERIFIX SOFT TIP N/A PFS-Y18RW manufactured by B. Braun Melsungen Ag.
[119039803]
(b)(4). This report has been identified as b. Braun melsungen ag internal report # (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 used catheter and filter, clip, and 2pcs connector out of a perifix filter set. Visual inspection: the catheter is broken 142mm away from tip. The tip of the catheter is kinked and twisted. The catheter was microscopically tested. The catheter resembled a state cut with micro scissors. The catheter is stretched from the tip to the middle. Dimensions check: length: received catheter: 1094mm, standard: 1002. 5mm - 1017. 5mm, (unused catheter length: 1009mm), the catheter is stretched. We guessed that it was stretched in surgical procedure. Review manufacturing record (perifix filter set). We checked our manufacturing records and any abnormality was not found. We assume a problem during application. This complaint is not confirmed. We have informed our manufacturer of the catheter accordingly and requested a batch review of the involved catheter perifix one. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[119039804]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): catheter was broken and the fragment is remained in the patient's body. Patient: (b)(6) years old. Has scoliosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00179 |
| MDR Report Key | 7837189 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-31 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-08-03 |
| Date Facility Aware | 2018-08-31 |
| Report Date | 2018-12-14 |
| Date Reported to FDA | 2018-12-14 |
| Date Reported to Mfgr | 2018-12-14 |
| Date Mfgr Received | 2018-08-06 |
| Date Added to Maude | 2018-08-31 |
| 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 | 2018-08-31 |
| Returned To Mfg | 2018-08-16 |
| Model Number | N/A |
| Catalog Number | PFS-Y18RW |
| Lot Number | 18E30H81YR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-08-31 |