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..
[183152619]
(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
[183152620]
Medwatch # (b)(4). Description of event: (b)(6) 2020 at 1345, epidural placed by anesthesiologist: positioned sitting upright, approach midline, needle (# 17 gauge, placed via loss of resistance technique (with air), catheter inserted into epidural space:5 cm; insertion level: l3/4 aspiration (no paresthesia noted, not blood, not cerebral spinal fluid), injectant (test dose given (lidocaine 1. 5% w/ epinephrine 1:200000, 3ml), no change in maternal hr, no signs of intravascular or intrathecal injection with test dose). Baby delivered vaginally at 1630. At 1855, rn began removing the catheter when slight resistance was met. Rn asked patient to reposition and arch back more towards rn to aid with removal. Rn again attempted to remove catheter with less resistance noted following position change. Gentle traction was applied to remove the catheter and catheter began to come out when rn noted that something appeared abnormal with the epidural catheter. Rn immediately stopped the catheter removal and called the in-house crna to come and evaluate the epidural catheter. At 1900 the crna noted: the plastic material of catheter was found to be broken at about the 17 cm mark with only the internal metallic wire reinforcement remaining connecting the broken catheter to the remaining portion of the catheter inside the patient. The crna called the anesthesiologist who came to the bedside. Per the anesthesiologist: 1913 "called to see patient, epidural catheter not coming out properly. When i examined the patient unsheathed wire protruding from patient's back with proximal epidural catheter attached. With application of minimal tension short section of wire came out of skin without tip of catheter present. Nurse reported that epidural was sliding out routinely, when it suddenly stopped, and the wire appeared. She immediately stopped and called us to evaluate the patient. It is my impression there is residual catheter left in the patient. Just how much is difficult to judge from the fragment available for exam. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2020-00088 |
| MDR Report Key | 9824499 |
| 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 |
| Device Manufacturer Date | 2019-10-03 |
| 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 |
| 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 | 23F19J0388 |
| 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 | 2020-03-12 |