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 2019-05-06 for INOJECT NEEDLE 74425-30/10 manufactured by Ambu A/s.
[144170492]
No sample has been returned to ambu for investigation. A retention sample and samples from lots produced before and after the lot from where the product concerned originate from, where checked by visual inspection. No broken or bent needles where observed. Production records on the finished good and supplier records on the canula, where inspected and all testing performed had passed. Simulated testing was carried out to detect if the needle breaks off from the hub when bent in wide angle position. The testing showed that the bigger the bending angle, the more likely the needle was to break. It is suspected, that the cause of the needle breaking of from the hub is multiple wide angle bending during insertion by user.
Patient Sequence No: 1, Text Type: N, H10
[144170494]
After medication was injected, needle came out of the hub and stayed in pediatric patient's leg when doctor attempted to pull it out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610691-2019-00006 |
| MDR Report Key | 8582917 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-06 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-04-05 |
| Date Facility Aware | 2019-04-05 |
| Report Date | 2019-04-08 |
| Date Reported to Mfgr | 2019-04-08 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-05-06 |
| 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 | SANJAY PARIKH |
| Manufacturer Street | 6230 OLD DOBBIN LANE SUITE 250 |
| Manufacturer City | COLUMBIA MD 21045 |
| Manufacturer Country | US |
| Manufacturer Postal | 21045 |
| Manufacturer Phone | 4107686464 |
| Manufacturer G1 | AMBU INC |
| Manufacturer Street | 6230 OLD DOBBIN LANE SUITE 250 |
| Manufacturer City | COLUMBIA MD 21045 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOJECT NEEDLE |
| Generic Name | INOJECT NEEDLE ELECTRODE |
| Product Code | IKT |
| Date Received | 2019-05-06 |
| Catalog Number | 74425-30/10 |
| Lot Number | 1000098146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | BALTORPBAKKEN 13 BALLERUP, DK 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-06 |