MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J

Catalog Number 515008

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while a hcp was preparing 100mg and 30 mg of paclitaxels, coring resulted leaving a fragment of rubber or membrane was inside the syringe of a bd phaseal¿ injector luer lock n35.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: visual inspection of membrane for injector luer lock(with syringe) according to (b)(6) report no fm was found inside the vial.No anomalies have been found in membranes, rubber stopper of vial and injector¿s cannula.Phaseal needles are designed to reduce the coring tendency.If coring comes from membrane: human error: performing multiple injections on the membrane could lead to fragmentation.Machines: if membrane is excessively welded, consistency is higher and elasticity lower, and once it is pierced by the needle, it could provoke membrane fragmentation.If coring comes from rubber stopper: materials: rubber stopper.Quality of rubber stopper will impact the occurrence of particles.The larger the percentage of inorganic filler in the rubber stopper, the more often cores and fragments will be produced.Capping conditions have shown to have significant effect on coring tendency.The type of crimping device used as well as the sealing force will have an influence on coring.Materials: needles.Design and dimensions of the needle influence the tendency for coring, especially regarding the production of larger cores, cut out from the rubber stopper by the needle edges.Phaseal needles are designed to reduce occurrence of coring.Misuse by the user: if the user makes a bad connection or turn the protector on the cap of the vial rather than insert it vertically, the cannula of the protector because of the rubbing with the stopper of the vial may cause detachment of particles from the cap of the vial.It is recommended to carefully follow the instructions explained in the ifu.For every manufactured lot the laboratory technician made the particles fragmentation test according to the (b)(4) procedure.The test is carried out within a in a laminate flow hood.Staff has to wear a lab coat, cap and gloves.Conclusion: no fm was found inside the vial.As the lot is unknown, dhr cannot be reviewed.No absolute root cause could be determined.Based on the low severity and frequency of the defect (according to (b)(4) and acceptable results for the sample evaluated, it was determined that no capa is required.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35J
• Type of Device: INJECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7059429
• MDR Text Key: 93713504
• Report Number: 3003152976-2017-00134
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other