MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-12 for EPIDURAL CATHETERIZATION KIT AK-05503 manufactured by Arrow International Inc..
[183138419]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[183138420]
Medwatch # (b)(4). Epidural catheter placed by anesthesiologist; he notes positioned sitting upright, approach midline, needle (#17 gauge, placed via loss of resistance technique (saline), depth of epidural space: 7cm; catheter depth at skin: 10cm; catheter inserted into epidural space: 3cm; insertion level: l2-3. Post-delivery the nurse tried to remove the catheter and met resistance, so she stopped. She called the charge rn who positioned the patient, then attempted to pull out the catheter, but also met resistance and stopped. The crna was called. He attempted and when he pulled the catheter, it snapped/broke. At that point, the anesthesiologist was notified. He could see a bit of the catheter poking out of the skin, so he numbed the area and attempted to grasp the end of it from under the skin. He was unable to retrieve the catheter and because of the tension, it coiled back into the back. Afterwards, the anesthesiologist noted that there was no obvious problem with the catheter and no visible knots on ct. He indicated that perhaps he could have removed it with some positioning techniques. For this reason, i do not believe this retained broken epidural catheter was caused by a catheter defect; but i did want the fda and manufacturer to be aware of this. The following day the patient went to surgery and had the 7. 5cm catheter piece removed from her back. It is available in our pathology department for inspection but we will not be releasing it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2020-00087 |
| MDR Report Key | 9824342 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-22 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-22 |
| Date Added to Maude | 2020-03-12 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPIDURAL CATHETERIZATION KIT |
| Generic Name | ANESTHESIA CONDUCTION CATHETER |
| Product Code | BSO |
| Date Received | 2020-03-12 |
| Catalog Number | AK-05503 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |