MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO 3 ML BD LUER-LOK LUER-LOK TIP; SYRINGE

Model Number 309657

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

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 a damaged stopper was found before use with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter, "the black rubber stopper on the plunger of the syringe was disfigured.".

Event Description

It was reported that a damaged stopper was found before use with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter, "the black rubber stopper on the plunger of the syringe was disfigured.".

Manufacturer Narrative

H.6 investigation summary: since no samples displaying the condition reported are available for examination, it was impossible to fully investigate this incident, therefore a root cause could not be determined.Furthermore, 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.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.H3 other text : see h.10.

• Brand Name: 3 ML BD LUER-LOK LUER-LOK TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 9512921
• MDR Text Key: 195043472
• Report Number: 9614033-2019-00297
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: 8345764
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other