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

Model Number 309657

Device Problem Leak/Splash (1354)

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

Event Date 11/16/2019

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 the needle hub was damaged with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter: it was reported the syringe hub where the needle screws in was uneven.Description of issue: syringe hub where needle screws in was uneven number of occurrences: 1.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Proceed to step 4.Item number, 3 ml syringe 309657, 26 g, 3/8¿ needle 305110, product lot number: needle: 9029658, syringe: 8290715 for bd product only, are samples available for investigation? no.Did issue cause any injury? if yes, what type of injury? caused air bubbles and high bg.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.

Event Description

It was reported that the needle hub was damaged with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter: it was reported the syringe hub where the needle screws in was uneven.1.Description of issue: syringe hub where needle screws in was uneven.2.Number of occurrences: 1.3.Did the customer insert the needle into the cartridge.And encounter fill resistance? no.Proceed to step 4.4.Item number : 3 ml syringe ¿ 309657 26 g, 3/8¿ needle ¿ 305110 5.Product lot number: needle: 9029658, syringe: 8290715; 6.For bd product only, are samples available for investigation? no.7.Did issue cause any injury? if yes, what type of injury? caused air bubbles and high bg.8.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.

Manufacturer Narrative

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.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.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.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: 3 ML BD LUER-LOK LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 9526616
• MDR Text Key: 202043410
• Report Number: 9614033-2019-00301
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

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: 10/31/2023
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: 8290715
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR