MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-15 for BOJECT NEEDLE 9013S0442 manufactured by Alpine Biomed Aps.
[70090627]
The lot history record will be reviewed with special attention to the manufacturing and inspection of this product. Customer has also been contacted to advise on the patient health status and the outcome of the surgery.
Patient Sequence No: 1, Text Type: N, H10
[70090628]
Translation of customer report: the needle had twisted several times before because the patient was moving, the brain injury that he presents causing a lack of control of the reflexes, his muscles are deep and powerful because it makes (b)(6). The fact that the needle twists did not worry me because it is very thin (37 mmx0. 41 mm, 27 g) and this has already happened to me without consequence. This time the needle broke when it was inserted into its support and when i pulled out the pressure on the muscle, it was buried in the muscle, i could not remove it, it will be removed at the operating room of the clinic of (b)(6) by dr. (b)(6) on monday (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2017-00003 |
| MDR Report Key | 6405852 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-15 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-02-23 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-03-15 |
| 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 | MR. MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 35391 6474 |
| Manufacturer G1 | BIOENGINEERING LABORATORIES SRL |
| Manufacturer Street | VIA CESARE CATTANEO, 20 |
| Manufacturer City | CANT 22063 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 22063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOJECT NEEDLE |
| Generic Name | DISPOSABLE HYPODERMIC NEEDLE |
| Product Code | IKT |
| Date Received | 2017-03-15 |
| Model Number | 9013S0442 |
| Catalog Number | 9013S0442 |
| Lot Number | N-2016-06-009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPINE BIOMED APS |
| Manufacturer Address | TONSBAKKEN 16-18 SKOVLUNDE, DENMARK DK2740,DA DA DK2740,DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-15 |