MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-02 for PORTEX? CSECURE? SPINAL AND EPIDURAL NEEDLE ASSEMBLY - MINIPACK 100/491/716 manufactured by Smiths Medical Asd, Inc..
[81791884]
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[81791885]
It was reported that the epidural catheter of a portex? Csecure? Spinal and epidural needle assembly - minipack fractured in the patient during removal, with the distal 4. 5cm remaining in the patient's back. The patient had a combined spinal-epidural (cse) for analgesia during labor. The epidural space was located at 5cm using a standard loss of resistance technique, with 4cm threaded into the epidural space. The cse procedure was performed at the first attempt and was uncomplicated, providing effective pain relief in labor, with spontaneous vaginal delivery occurring approximately an hour after cse procedure. When the epidural catheter was removed after delivery, the epidural catheter was found to be fractured, with the distal 4. 5cm in the patient's back. There was nothing to see or feel on inspection of the lower lumbar spine. The area around the patient's bed was carefully inspected for the missing segment of the epidural catheter. The epidural catheter did not show any sign of being stretched or frayed. There was a 45 degree clean transection 0. 5cm below the 5cm mark. The patient was then referred to neurosurgeon. An mri was performed together with a plain lumbar spine x-ray. The retained fragment of epidural catheter was not seen on the mri scan or plain x-ray. It was decided that no further imaging or intervention would be provided. No permanent injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[107888962]
Photographs of the device were received for investigation. From the photographs, it was observed that the tip of the closed end of the catheter was broken. A manufacturing review of a similar device was performed and no discrepancies were found. The most probable root causes were attributed to manufacturing deficiency or outside causes: the tip of the catheter was damaged during the end closed forming operation. The damage in the closed end of the catheter was not detected per visual inspection performed in the manufacturing process. The broken closed end of the catheter was attributed to a post manufacturing situation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-01665 |
| MDR Report Key | 6760902 |
| Date Received | 2017-08-02 |
| Date of Report | 2018-04-27 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-07-14 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2017-08-02 |
| 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 | JENNIFER MENG |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833078 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | 52 GRAYSHILL ROAD |
| Manufacturer City | CUMBERNAULD, GLASGOW G68 9HQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | G68 9HQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTEX? CSECURE? SPINAL AND EPIDURAL NEEDLE ASSEMBLY - MINIPACK |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2017-08-02 |
| Catalog Number | 100/491/716 |
| Lot Number | 3392516 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-02 |