MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK¿ TIP DISPOSABLE SYRINGE; PISTON SYRINGE

Model Number 309657

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It was reported that the luer of the bd luer-lok¿ tip disposable syringe cracked during the im injection, and two drops of medication leaked out.The following information was provided by the initial reporter: "3ml syringe small crack visualized at luerlock area.23g 1" tip was attached and uncompromised.Cracked during im injection, 2 drops of medication visualized leaking from syringe.Impact of incident: patient aware of crack and missed medication due to same, will monitor and return for next medication administration.No further incident.".

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 luer of the bd luer-lok¿ tip disposable syringe cracked during the im injection, and two drops of medication leaked out.The following information was provided by the initial reporter: "3ml syringe small crack visualized at luerlock area.23g 1" tip was attached and uncompromised.Cracked during im injection, 2 drops of medication visualized leaking from syringe.Impact of incident: patient aware of crack and missed medication due to same, will monitor and return for next medication administration.No further incident.".

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD LUER-LOK¿ TIP DISPOSABLE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15013218
• MDR Text Key: 303992733
• Report Number: 9614033-2022-00059
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: 1011650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial