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

Catalog Number 309657

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 before use, that the customer filled the syringe with insulin but when attempting to fill the cartridge with this insulin the plunger wouldn't move which made the 3 ml bd luer-lok¿ disposable syringe with bd luer-lok¿ tip unusable.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD 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 ; 8015652845
• MDR Report Key: 7003942
• MDR Text Key: 92477073
• Report Number: 1213809-2017-00242
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096572
• UDI-Public: 00382903096572
• 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
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2017
• 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