MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for BD?PHASEAL? INJECTOR LUER LOCK N35C 515004 manufactured by Becton Dickinson, S.a..
[99997356]
Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. Investigation: the sample was received activated. The grips were damaged and they were out of their place. The needle is exposed. The injector was deactivated by quality technician and the grips place in their original position, the needle remained inside the safety sleeve. Taking into account that the grips were found damaged and out of their place, it seems that the defect was caused during the use. To avoid needle exposure, it is important to hold onto the white part of the injector before engaging/disengaging. Do no touch the blue part: if grips of the safety sleeve are removed from their place, the injector is activated and cannula causing needle exposure. The injector must be removed pulling it back: if it is removed without doing this the grips are removed from their place and needle exposure happens. If the injector has been forced while engaging, the grips can also get damaged. Several tests and inspection are carried out to avoid faulty parts. Among them, the functionality of the injector is verified. Visual inspection is also performed to assure that there are no damages/dirty components. As the lot is unknown, device history record cannot be checked. Broken safety sleeve the sample was received activated. The grips were damaged and they were out of their place. The needle is exposed. If the injector is deactivated and the grips place in their original position, the needle remains inside the safety sleeve. Inspections and tests: the tests performed during the manufacturing process to avoid faulty parts are listed below: during molding process (according ph-300 current version): visual inspections for injector parts (cylinder, needle housing, safety sleeve, piston and membrane) are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc). Critical to quality dimensions of all injector components are measured to check if the dimensions are within tolerance. Assembly process: (according to ph-301 current version) the following visual inspections are performed by the operator: safety sleeve must be connected and should be turning with the cylinder and piston. The functionality of the grips is verified. Verify the correct welding of the membrane, color and aspect. Cylinder assembly. Piston must be fixed by the safety sleeve. Needle housing should rotate clockwise and tip of the cannula must be observed. Cannula length (with a calliper gauge). Functionality and piston welding test: quality and functionality of the membrane is verified after be welding and penetrated by the cannula. Conclusion: taking into account that the grips were found damaged and out of their place, it seems that the defect was caused during the use. The injector was deactivated by quality technician and the grips place in their original position, the needle remained inside the safety sleeve. As the lot is unknown, the dhr and retained samples cannot be checked. Taking into account that the grips were found damaged and out of their place, it seems that the defect was caused during the use.
Patient Sequence No: 1, Text Type: N, H10
[99997357]
It was reported that there was a needle safety failure of a bd phaseal? Injector luer lock n35c. There was no report of injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003152976-2018-00023 |
| MDR Report Key | 7261062 |
| Date Received | 2018-02-09 |
| Date of Report | 2018-01-19 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-01-16 |
| Date Added to Maude | 2018-02-09 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON, S.A. |
| Manufacturer Street | CAMINO DE VALDEOLIVIA S/N |
| Manufacturer City | SAN AGUSTIN DE GUADALIX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD?PHASEAL? INJECTOR LUER LOCK N35C |
| Generic Name | INJECTOR |
| Product Code | ONG |
| Date Received | 2018-02-09 |
| Returned To Mfg | 2018-02-08 |
| Catalog Number | 515004 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON, S.A. |
| Manufacturer Address | CAMINO DE VALDEOLIVIA S/N SAN AGUSTIN DE GUADALIX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-09 |