MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for DYNJ46134C manufactured by Argon Medical Devices (manan Medical Products).
[120534446]
It was reported that the patient, who was undergoing cardiac catheterization, required a second puncture to an unidentified artery after an initial unsuccessful attempt on the femoral artery using a dull gauge 18 introducer needle. Per report, a different introducer needle was used and the procedure continued without further incident. Additional sedation was reportedly not required. There was no report of any complications and no effect on the patient's stability as a result of the incident. No impact to the patient, the procedure, or the total length of the procedure was reported. There was no serious injury or follow up care reported related to the event. Due to the reported need for a second puncture and in an abundance of caution, this medwatch is being filed. The sample was returned and the reported complaint of dull introducer needle was confirmed. The manufacturer of the introducer needle has been notified of this incident. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[120534447]
It was reported that a second puncture was required after an initial unsuccessful attempt using a dull introducer needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00049 |
| MDR Report Key | 7876496 |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-08-20 |
| Date Added to Maude | 2018-09-14 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | INTRODUCER NEEDLE FROM CATH N0 1 STRL MMC PACK |
| Product Code | OES |
| Date Received | 2018-09-14 |
| Returned To Mfg | 2018-08-31 |
| Catalog Number | DYNJ46134C |
| Lot Number | 18EDC167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES (MANAN MEDICAL PRODUCTS) |
| Manufacturer Address | 241 PALATINE RD WHEELING IL 60090 US 60090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-14 |