MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-07-31 for ARROW CONTINUOUS NERVE BLOCK KIT FB-19608-K manufactured by Arrow Intl., Inc..
[4800285]
Complaint alleges tha the lidocaine ampule "crushed" when the tech tried to open it. The alleged defect occurred during a nerve block procedure on a patient. There were no reports of patient harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[11996173]
The customer returned broken pieces of a medication ampule. The returned glass pieces were visually examined with and without magnification. Visual examination revealed that not all pieces appear to have then returned. The top of the vial was returned intact and broken cleanly at the score line. A device history (dhr) review was performed on lidocaine ampules with no relevant findings. The reported complaint of ampule crushed upon opening was confirmed based on the condition of the sample received. A portion of the medication ampule was returned in several pieces. However, the top that was returned appears to have broken along the score line as intended, indicating that there are no abnormalities in the score line. The entire ampule was not returned. A dhr review was performed on the lidocaine ampules with no evidence to suggest a manufacturing related cause. Therefore, the potential root cause of this complaint could not be determined a conclusion code could not be chosen as the complaint was confirmed, however, a root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00304 |
| MDR Report Key | 4029938 |
| Report Source | 06,07 |
| Date Received | 2014-07-31 |
| Date of Report | 2014-07-11 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2014-07-11 |
| Date Added to Maude | 2014-09-02 |
| 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 | 0 |
| 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 CONTINUOUS NERVE BLOCK KIT |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | OGJ |
| Date Received | 2014-07-31 |
| Returned To Mfg | 2014-07-18 |
| Catalog Number | FB-19608-K |
| Lot Number | 23F14A1695 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTL., INC. |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-31 |