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

Catalog Number 515008

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

It was reported that a polypropylene particle was found in the needle of the bd phaseal¿ injector luer lock n35j.The following information was provided by the initial reporter, translated from (b)(6): "the customer found anomaly within n35." via bd investigation: "the injector was disassembled for further evaluation and found the needle of the injector was partially clogged by a polypropylene particle.".

Manufacturer Narrative

Investigation summary: one injector sample was provided to our quality team for investigation.The product was visually inspected and no damage or defects were observed, the injector was able to fully engage with the mating connector without issue.Functional testing was performed, connecting the injector to a c90 connector.While fluid was able to properly flow through both devices, it was noted to pass more slowly.The injector was disassembled for further evaluation and found the needle of the injector was partially clogged by a polypropylene particle.A device history review was performed for lot 2107012, no deviations or non-conformance's were identified during the manufacturing process that could have contributed to this issue.Product undergoes visual and functional inspections prior to release, including verification the product is not damaged, flow rate, and all critical dimensions meet specifications.Upon reviewing the results for lot 2107012, no issues were identified during testing and the product met the required criteria for release.While we cannot identify a direct issue, this incident is likely related to a failure in the assembly machine, which may have lead to the to improper positioning of the cannula when inserted into the needle housing and can result in the polypropylene becoming pulled into the cannula, creating an occlusion.Manufacturing personnel have been notified of this incident to increase awareness.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35J
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14131561
• MDR Text Key: 289760163
• Report Number: 3003152976-2022-00145
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 515008
• Device Lot Number: 2107012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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