MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515003

Device Problems Product Quality Problem (1506); Structural Problem (2506)

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

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be performed as no lot information was provided.Based on the available information we were not able to fully investigate this issue therefore a root cause cannot be determined at this time.Although the defect was not confirmed for this instance, bd has recently investigated a similar complaint for this product and found that coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.The use of the m12 assembly fixture is recommended to ease proper connection to the vial.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.Investigation conclusion: provide results, any testing performed, and other relevant information.Conclusion(s): coring.Customer complaints about coring.No samples or pictures were provided.No lot.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.Materials: needles.See below.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 it-1730 procedure.The test is carried out within a in a laminate flow hood.Staff has to wear a lab coat, cap and gloves.Root cause description: as several factors impact on coring tendency, the root cause cannot be established.Note: there were no changes in phaseal protectors recently.The use of assembly fixture m12 is recommended.

Event Description

It was reported that bd phaseal¿ injector luer lock n35 had coring.No serious injury or medical intervention was reported.Verbatim: "material no.515003 batch no.Unknown.It was reported there was coring."we have had some coring with the following vials when using phaseal protectors; carfilzomib, trastuzumab, rituximab, pembrolizumab.It seems to have been happening more in the last couple of weeks.Have you changed your protectors at all? the protector used was p50 no we don't record the lot code of any phaseal¿ components.Perhaps we should be.We have ceased using phaseal on trastuzumab because it is a multi-dose vial and we can give it a 28 day expiry date.Carfilzomib is a drug which we are starting to use more of.Fortunately the core was large enough that we were able to isolate it in the vial.Although we did change the injector prior to injecting into the bag which actually ¿opened¿ up our closed system.This medication also has to be reconstituted so i am not sure if that has anything to do with this problem.Pembrolizumab was compassionate stock which was expiring the end of january and we were fortunate enough to have enough vials to use.I did however try this drug three times.The first two times we had coring when using phaseal therefore i resorted to using a conventional needle since we couldn't afford to waste any more drug.We have had no problems using phaseal on rituximab until last week when we noticed a core.There was no chemo exposure to staff or any major injuries.No courses of treatment changed.Yes the products were discarded.Initially we weren't using phaseal on the mab¿s but since napra has been implemented, most of our mab¿s are single-use vials and we would have had to waste some very expensive medications.We are using the phaseal to extend our bud¿s.Please note that while the customer is reporting an incident with the protector p50, this incident would also involve the injector n35 (515003)."".

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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 ; 8015652341
• MDR Report Key: 8395857
• MDR Text Key: 139094300
• Report Number: 3003152976-2019-00190
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150037
• UDI-Public: 30382905150037
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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