MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for SURECAN SAFETY II 4447007 manufactured by B.braun Medical Sas.
[146636071]
(b)(4). Batch history review: a batch record review for the reported lot number did not reveal any abnormalities or non-conformances of this nature. Another similar complaint has been reported on this batch of needles by the same end customer (9612452-2019-00073). Investigation: 21 unused needles from the same batch were received for evaluation. The safety mechanism of 5 needles was tested, and it could be activated without any difficulties. The activation forces are compliant with the specification. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number. Conclusion: based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event. The returned devices met requirements according to specification, and the reported failure could not be reproduced. If additional pertinent information becomes available a follow-up report will be filed. This report is being filed for an item number, 4447007, that is not sold in the united states, however a similar item, 4447007-02, is sold in the united states by b. Braun medical, inc.
Patient Sequence No: 1, Text Type: N, H10
[146636072]
As reported by user facility (in (b)(4)): safety plate dysfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612452-2019-00075 |
| MDR Report Key | 8648112 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2018-09-01 |
| Date Added to Maude | 2019-05-28 |
| 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 | MRS CATHERINE BOISMENU |
| Manufacturer Street | 30, AVENUE DES TEMPS MODERNES |
| Manufacturer City | CHASSENEUIL DU POITOU, 86361 |
| Manufacturer Country | FR |
| Manufacturer Postal | 86361 |
| Manufacturer G1 | B.BRAUN MEDICAL SAS FRANCE |
| Manufacturer Street | 30, AVENUE DES TEMPS MODERNES |
| Manufacturer City | CHASSENEUIL DU POITOU, 86361 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 86361 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURECAN SAFETY II |
| Generic Name | NON-CORING (HUBER) NEEDLE |
| Product Code | PTI |
| Date Received | 2019-05-28 |
| Returned To Mfg | 2019-05-09 |
| Model Number | 4447007 |
| Lot Number | 18K11G8671 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN MEDICAL SAS |
| Manufacturer Address | 26 RUE ARMENGAUD SAINT CLOUD, 92210 FR 92210 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |