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

Model Number 309657

Device Problem Break (1069)

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

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Initial reporter occupation: sr.Global post market surveillance.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.Root cause description: since no samples displaying the reported condition were received a potential root cause could not be defined.Since no samples displaying the reported condition were received corrective actions are not necessary.

Event Description

It was reported that 4 3 ml bd luer-lok¿ luer-lok¿ tips experienced a broken needle during use.The following information was provided by the initial reporter: material no: 309657, batch no: unknown.Event description: number of occurrences - 4 cartridges.Did the caller insert the needle into the cartridge and encounter fill resistance? - no.Product with issue - bd 3ml syringe, pn 309657.Product lot # - unavailable.Did issue cause any injury? - no.Did customer require medical intervention? - no.Is product manufactured by bd? - yes.Caller reported needle bent/broken during loading process of 4 cartridges starting on (b)(6) 2020.

• Brand Name: 3 ML BD LUER-LOK 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10597937
• MDR Text Key: 209854598
• Report Number: 1213809-2020-00668
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 22 YR