MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-05 for FLEXIMA CATHETER UNK540 manufactured by Boston Scientific - Costa Rica (coyol).
[113178185]
(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113178186]
It was reported via (b)(4) that the hub of the drain cracked. A 12f apd flexima drainage catheter was implanted in the patient's right chest. However, 5 days after the procedure, the nurse observed that the patient's bed was wet and was coming from the catheter. The drain was pulled from the patient's body where it was noted that the drain was cracked at the white hub. The drain was replaced with another of the same device. No patient complications reported and the patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-06529 |
| MDR Report Key | 7663544 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-08-22 |
| Date Added to Maude | 2018-07-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIMA CATHETER |
| Generic Name | TUBE, DRAINAGE, SUPRAPUBIC |
| Product Code | FFA |
| Date Received | 2018-07-05 |
| Returned To Mfg | 2018-07-20 |
| Model Number | UNK540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |