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 2015-02-12 for ARROW CONTINUOUS NERVE BLOCK KIT AB-20608-KS manufactured by Arrow Intl., Inc..
[18035437]
The clinician noticed that the distal end of the catheter was sheared and approx 3cm of the sheathing came off the catheter and remained in the (b)(6) 2015 and removal of the catheter was on (b)(6) 2015. No report of patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[18319293]
(b)(4). Additional info from user facility: the patient declined having the fragment removed and was discharged from the hosp; f/u on patient condition indicates that the patient has pain relief and no redness or swelling at the catheter site. A visual, functional and dimensional inspection could not be performed as no sample was returned by the customer for investigation. A device history record review was performed on the 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 analysis. A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of catheter separation could not be determined based upon the info provided and without a sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2015-00036 |
| MDR Report Key | 4523881 |
| Report Source | 05,06,07 |
| Date Received | 2015-02-12 |
| Date of Report | 2015-01-20 |
| Date of Event | 2015-01-20 |
| Date Mfgr Received | 2015-01-20 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-03-13 |
| 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 CONTINUOUS NERVE BLOCK KIT |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2015-02-12 |
| Catalog Number | AB-20608-KS |
| Lot Number | 23F14F0289 |
| Device Expiration Date | 2015-11-30 |
| 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 | ASHEBORO NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-12 |