MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-24 for AMBU NEUROLINE INOJECT NEEDLE 74438-45/10 manufactured by Ambu A/s.
[90151723]
Only hub was returned for investigation. Dented mark was observed on the complainant sample hub. From the simulation test result, the bending angle around 40o and 70o will cause the needle (cannula) to break off after 45 times and 12 times of bending at opposite direction respectively. Second simulation test was performed by penetrating the needle to the hard surface (simulation of penetration to patient with harder muscle /in contact with bone) to see the needle condition during penetration and to see where the needles breaks off. Simulation test determined that the needle would start to bend when entered into hard surface. The bending point of the needle was shifted from the middle of the needle to the intersection between the hub and the needle when the penetration angle was increased. Based on the simulation tests, we can conclude that the bigger bending angle could break needle from the hub. The condition became worse if the bending fulcrum was at the intersection between the hub and the needle especially when the penetration was done on the harder surface (muscle) or hit the bone. It is suspected that the needle was bent at wide angle which caused the needle to break from the hub. For the last 12 months, complaint rate is at 0 cppm. This event was caused by use error.
Patient Sequence No: 1, Text Type: N, H10
[90151724]
When patient was receiving injection at right lateral hip region, the needle broke off at the hub when injecting. Surgery was performed to remove the needle but unable to retrieve needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610691-2017-00008 |
| MDR Report Key | 6974476 |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-09-22 |
| Date Facility Aware | 2017-09-22 |
| Report Date | 2017-09-22 |
| Date Reported to Mfgr | 2017-09-22 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-24 |
| 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 | MR. 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 | AMBU NEUROLINE INOJECT NEEDLE |
| Generic Name | ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH - INOJECT NEEDLE |
| Product Code | IKT |
| Date Received | 2017-10-24 |
| Catalog Number | 74438-45/10 |
| Lot Number | 1957984 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-24 |