MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-10-25 for COCENTRIC NEEDLES 74025-30/25 manufactured by Ambu A/s.
[124982367]
The used needle was discarded. A box of needles from the same lot was returned for investigation purposes, and a photo and a x-ray image of the fault were received. Visual inspection of the received images could verify the reported failure, as the needle was found to be broken, and the needle tip was shown on the x-ray, inside the patient. Based on the investigation it is highly suspected that the cause of the needle break are due to excessive force during insertion in combination with multiple wide angle bending. Is it suspected that the handling of the needle under such conditions has weakened the needle strength, leading to the failure. Investigations were carried out, to simulate the rough bending of the needle. The tested needles behaved within specifications. During normal usage, there is no danger that the needle will break because they are designed to withstand many times of bending within the flexible limit. The reported problem is included in the product risk analysis. The risk for a hazardous situation to occur as a result of the reported problem is concluded to be acceptable low. The current report does not result in a change of the risk assessment. The observed complaint rating is within the probability level identified in the product risk.
Patient Sequence No: 1, Text Type: N, H10
[124982368]
The needle was used on the left thigh of a female patient. During the procedure, the needle tip broke of and remained in the patient. The patient had to go through x-ray screening and surgery to remove the needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610691-2018-00006 |
| MDR Report Key | 8004554 |
| Report Source | FOREIGN |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-27 |
| Date Facility Aware | 2018-10-04 |
| Date Mfgr Received | 2018-09-27 |
| Date Added to Maude | 2018-10-25 |
| 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 21048 |
| Manufacturer Country | US |
| Manufacturer Postal | 21048 |
| 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 | COCENTRIC NEEDLES |
| Generic Name | ELECTRODE NEEDLE DIAGNOSTIC |
| Product Code | IKT |
| Date Received | 2018-10-25 |
| Catalog Number | 74025-30/25 |
| Lot Number | 1970438 |
| 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 | 2018-10-25 |