MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for DYNJRA1118 manufactured by Medline Industries Inc..
[138797373]
It was reported that during a left occipital injection of bupivacaine 0. 25%, omnipaque, and betamethasone, the 1? Inches gauge-25 injection needle (taken from the pain tray) broke off from the hub of the needle into the patient. Reportedly, no excessive force was applied against or to the needle and the incident reportedly occurred as end user was withdrawing the needle from the injection site. The needle was successfully retrieved through fluoroscopy-guided extraction. It was confirmed through x-ray that no needle fragment was left in patient. Per report, no additional sedation medication was required related to this incident. Due to the reported incident and required medical intervention to retrieve the needle from the patient, this medwatch is being filed. The sample is not available to be returned for evaluation. A definitive root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[138797374]
It was reported that an injection needle broke off from its hub into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00026 |
| MDR Report Key | 8404024 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2019-03-08 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | INJECTION NEEDLE FROM PAIN TRAY |
| Product Code | OFT |
| Date Received | 2019-03-08 |
| Catalog Number | DYNJRA1118 |
| Lot Number | 18FBA666 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-08 |