MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-01 for DYNJ0665347I manufactured by Nipor Medical.
[68747181]
It was reported a needle broke off during a procedure and remained in the patient. The surgeon was injecting a subcutaneous anesthetic for a hernia repair. During the injection the needle "snapped off" right above the hub. The amount of pressure being applied during the injection is not known. The patient required a ct scan and a secondary surgery to remove the needle. No further information was made available. Sample was returned and issue confirmed. A root cause cannot be determined. Nipro medical is the manufacturer of the needle. They have been notified, will conduct an investigation and make the determination whether any corrective action is indicated. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[68747182]
It was reported a needle broke during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00005 |
| MDR Report Key | 6370137 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date Mfgr Received | 2017-02-10 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2017-03-01 |
| 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 | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NEEDLE IN CSMC MINOR LAP PACK |
| Product Code | FDE |
| Date Received | 2017-03-01 |
| Catalog Number | DYNJ0665347I |
| Lot Number | 16JK2210 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPOR MEDICAL |
| Manufacturer Address | 200 CROSSING BLVD BRIDGEWATER NJ 08807 US 08807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-01 |