MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY; PISTON SYRINGE

Catalog Number 309703

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

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 the tips of an unspecified number of bd luer-lok¿ syringes in the bulk sterile pharmacy convenience tray were broken/damaged and caused the syringes to leak.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "the tips of the syringes are dented/chipped and often causing the syringes to leak.We have seen 10-15 syringes with this defect so far.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 15sep2022.Investigation summary: our quality engineer inspected the 1 photo and 4 samples submitted for evaluation.The reported issue of tip breakage was confirmed upon inspection of the samples.Each sample was found to have collars that were slightly to heavily damaged and bent in.Bd determined that the cause of the failure was associated to the assembly process during manufacturing.Production records were reviewed, and this batch was in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported that the tips of an unspecified number of bd luer-lok¿ syringes in the bulk sterile pharmacy convenience tray were broken/damaged and caused the syringes to leak.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "the tips of the syringes are dented/chipped and often causing the syringes to leak.We have seen 10-15 syringes with this defect so far.".

• Brand Name: BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15405558
• MDR Text Key: 305543316
• Report Number: 1213809-2022-00560
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903097036
• UDI-Public: 00382903097036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309703
• Device Lot Number: 1327231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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