MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE

Catalog Number 300865

Device Problem Leak/Splash (1354)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It was reported that the bd plastipak¿ concentric luer lock syringe plunger advances itself (without being pushed) pushing the drug out thus it is leaking the drug.The following information was provided by the initial reporter: "the 50cc luer lok syringe is leaking drug.The plunger advances itself (without being pushed) pushing the drug out.".

Manufacturer Narrative

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.

Event Description

It was reported that the bd plastipak¿ concentric luer lock syringe plunger advances itself (without being pushed) pushing the drug out thus it is leaking the drug.The following information was provided by the initial reporter: "the 50cc luer lok syringe is leaking drug.The plunger advances itself (without being pushed) pushing the drug out.".

Manufacturer Narrative

H.6.Investigation summary: one sample along with one photo was provided to our quality team for investigation.Through visual inspection, no damage or other defects within the tip were observed.Testing was performed and found the luer fitting met required specification.A device history review was performed for reported lot 2102037, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Molding parameters were reviewed for the reported lot and found machines were operating within required limits.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.All results were reviewed for lot 2102037 and no issues related to the reported incident were found.Based on the sample evaluation and given the device records did not identify any failures related to this incident, we are not able to determine a root cause related to our manufacturing process at this time.H3 other text : see h.10.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• Type of Device: PISTON SYRINGE
• 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: 15026491
• MDR Text Key: 296980747
• Report Number: 3003152976-2022-00321
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UG
• 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,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300865
• Device Lot Number: 2102037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• 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