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 Chemical Exposure (2570)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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.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.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that leakage occurred during use with a 3 ml bd luer-lok¿ luer-lok¿ tip.The following information was provided by the initial reporter: it was reported that insulin accidently spilled out, customer was not sure if it was due to the syringe being damaged or user error."description of issue: customer reported insulin spilled out by accident.Customer is not sure if the spill was due to damage to the syringe or user error.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: 8290715 (syringe), 9829658 (needle), for bd product only, are samples available for investigation? no.Did issue cause any injury? if yes, what type of injury? no.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.

• 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
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9913725
• MDR Text Key: 204260722
• Report Number: 9614033-2020-00041
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR