MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-01-23 for ARROW SPINAL ANES/EPIDURAL CATH KIT ASK-05560-JMH1 manufactured by Arrow Intl., Inc..
[18931121]
The customer reports that the catheter broke off inside the pt. The issue occurred during the removal of the catheter. A resident was the person removing the catheter when the incident occurred. The customer also indicates that a piece of the device is still in the pt. The facility wanted to undergo an mri to determine the best course of action to take to remove the broken piece.
Patient Sequence No: 1, Text Type: D, B5
[19179941]
(b)(4). Visual, functional, and dimensional inspection could not be performed as no sample was returned by the customer for investigation. No lot number was provided by the customer for investigation. A dhr review was performed on lot number 23f14j1061 from sales history. A dhr review was performed on the epidural catheter with no relevant findings. A corrective action is not required at this time as a potential root cause could not be determined based upon the info provided and without a sample. Complaint verification testing could not be performed as no sample was returned for investigation. No lot number was provided. However, a dhr review was performed based on a sales history lot number. A dhr review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential root cause could not be determined based upon the info provided and without a sample. Note: additional info from facility requested. No updated info available at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00008 |
| MDR Report Key | 4451349 |
| Report Source | 05,06,07 |
| Date Received | 2015-01-23 |
| Date of Report | 2015-12-23 |
| Date of Event | 2014-12-23 |
| Date Mfgr Received | 2015-12-23 |
| Date Added to Maude | 2015-02-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | ARROW INTL., INC. |
| Manufacturer Street | 312 COMMERCE PL. |
| 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 | ARROW SPINAL ANES/EPIDURAL CATH KIT |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2015-01-23 |
| Catalog Number | ASK-05560-JMH1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTL., INC. |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-23 |