MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Catalog Number 309605

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 08/11/2022

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 bd syringe luer-lok¿ tip are dented/chipped often causing the syringe to leak.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 evalution?: yes.D10: returned to manufacturer on: 10-oct-2022 h6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, a severe indentation observed on the top of the barrel collar.Potential root cause for the damaged collar defect is associated with the assembly process.This condition is occurring below their expected frequency so no corrective action is required at this time.A device history record review was completed for provided lot number 1200434.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

Event Description

It was reported that the bd syringe luer-lok¿ tip are dented/chipped often causing the syringe to leak.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 SYRINGE LUER-LOK¿ TIP
• 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: 15491698
• MDR Text Key: 300709251
• Report Number: 1213809-2022-00644
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096053
• UDI-Public: 00382903096053
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309605
• Device Lot Number: 1200434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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