MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for BD PHASEAL? INJECTOR LUER LOCK N35 515003 manufactured by Becton Dickinson, S.a..
[94789611]
Date of event: unknown. The date received by manufacturer has been used for this field. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1603012. Medical device expiration date: 2018-08-31. Device manufacture date: 2016-03-31. Medical device lot #: 1603013. Medical device expiration date: 2018-08-31. Device manufacture date: 2016-03-31. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[94789612]
It was reported that the bd phaseal? Injector luer lock n35 fell off of the tubing, during use. There was no report of injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[117729631]
Investigation: flow issues: injector difficult to engage/disengage. No samples or pictures available. Two (2) retained samples of each lot have been evaluated. Visual inspection shows no defects. Luer lock threads of each sample are properly molded. One sample of each lot has been connected to a c50 and infusion bag: no issues found during connection (no disconnection, no leak occurred, no flow issues). The injectors were connected to a connector: no defects found. 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. The distance between the rotation stops is measured at the beginning of the lot and after a machine stop: go/ no go gauge. 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: no defects have been found in retained samples. No qn? S or other events found in dhr review for the two claimed lots. The root cause was not found. Based on the low severity and frequency of the defect (according to ps-001) and acceptable results for retained samples and manufacturing process, it was determined that no capa is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003152976-2017-00143 |
| MDR Report Key | 7079200 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-12-04 |
| 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 N35 |
| Generic Name | INJECTOR |
| Product Code | ONG |
| Date Received | 2017-12-04 |
| Catalog Number | 515003 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-12-04 |