MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-03-26 for PORTEX? EPIDURAL MAXIPACK manufactured by Smiths Medical Inc, Asd.
[103603252]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[103603253]
It was reported that a smiths medical device had an epidural catheter malfunction. During use on a patient, the catheter was reported to be snapped at the 6-8cm mark. It was reported that leaking occurred. The nursing team kept a part of the catheter and the distal 6-14cm of the catheter was discarded. It was noted that the catheter tip was intact. The device had been in use for 3 days. On the 3rd day in the late evening, the leaking was observed. Troubleshooting by the reporter determined that the catheter may have been accidentally cut through the dressing. It was observed that the catheter was in four pieces. The actual cause was unable to be confirmed by the reporter. The patient required an alternative form of analgesia. The patient was unharmed and was monitored until discharge. No further injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-00831 |
| MDR Report Key | 7371445 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-26 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? EPIDURAL MAXIPACK |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2018-03-26 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INC, ASD |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-26 |