MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-14 for BOJECT NEEDLE 9013S0442 manufactured by Natus Manufacturing Limited.
[111050559]
Manufacturer's preliminary analysis: device history record (dhr) requested, the dhr will be reviewed with special attention to the manufacturing and inspection of this product. Components of the needle requested to be returned. Medical device is not implantable. Medical device is not a single-use device that was reprocessed or reused on a patient. Device manufacture date: the dhr has been requested, expiration date will be obtained from this record.
Patient Sequence No: 1, Text Type: N, H10
[111050560]
During the injection of botulinum toxin into the posterior tibialis muscle for an obese spastic hemiplegic patient, a needle 9013s0442 (lot: n-2017-06-010) was twisted and broken at its junction with its support. Clinical consequences and current status of the patient: the needle remained in the posterior tibialis muscle of the patient. Action from the customer for the patient: radiological and clinical monitoring, no surgical intervention decided at the moment. Action from the customer: no recall of the product, report sent to (b)(6) by the customer.
Patient Sequence No: 1, Text Type: D, B5
[117897729]
Investigation is currently ongoing into the reported issue. Further information has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004827015-2018-00001 |
| MDR Report Key | 7600788 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-14 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-05-17 |
| Date Mfgr Received | 2018-05-18 |
| Date Added to Maude | 2018-06-14 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS LOUISE CALLANAN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOJECT NEEDLE |
| Generic Name | BOJECT DISPOSABLE HYPODERMIC NEEDLE |
| Product Code | IKT |
| Date Received | 2018-06-14 |
| Model Number | 9013S0442 |
| Catalog Number | 9013S0442 |
| Lot Number | N-2017-06-010 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-14 |