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 2014-10-16 for ARROW FLEXBLOCK KIT: ECHO CATH, 17GX4CM, STM NDL FB-19604-K manufactured by Arrow Intl., Inc..
[5095001]
Complaint alleges that the catheter would not thread through the needle. Catheter appeared to be kinked. The alleged defect occurred during use. There was no report of patient harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[12214274]
A device history record (dhr) review was performed on the stimulating needle and flexblock catheter with no relevant findings. The sample was not returned for evaluation, therefore, the complaint could not be confirmed. The dhr for the stimulating needle and flexblock catheter were reviewed with no evidence to suggest a manufacturing related cause. The potential cause of a catheter not threading through the needle could not be determined based upon the information provided and without a sample. If the sample is returned, a follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00412 |
| MDR Report Key | 4188217 |
| Report Source | 05,06,07 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-09-23 |
| Date of Event | 2014-09-22 |
| Date Mfgr Received | 2014-09-23 |
| Date Added to Maude | 2014-10-24 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| 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 FLEXBLOCK KIT: ECHO CATH, 17GX4CM, STM NDL |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2014-10-16 |
| Catalog Number | FB-19604-K |
| Lot Number | 23F14E1285 |
| 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 | 2014-10-16 |