MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	309580
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the attached needle bent and separated from the bd luer-lok¿ syringe during use, after drawing up medication.This caused the medicine to leak out before the shot could be administered.The medication was being used for a pregnancy, and the full dose was not received as a result of the leakage.The following information was provided by the initial reporter: "spouse stated, he was able to draw the medication, but it started to leak before he could administer the shot stated, the medication is for his wife's pregnancy.Stated, a piece of the syringe snapped off? stated, was not able to use medication that was drawn up and as a result, he had to pay out of pocket for more medication for his wife." "product number 309580.He stated he administers the medication to his wife, and in this particular incident, he stated the needle bent and got separated from the plunger resulting in the medication leaking out and his wife not getting the full amount she needed.Lot number is unknown and the date of event he provided is (b)(6) 2019.".
Event or Problem Description
It was reported that the attached needle bent and separated from the bd luer-lok¿ syringe during use, after drawing up medication.This caused the medicine to leak out before the shot could be administered.The medication was being used for a pregnancy, and the full dose was not received as a result of the leakage.The following information was provided by the initial reporter: "spouse stated, he was able to draw the medication, but it started to leak before he could administer the shot stated, the medication is for his wife's pregnancy stated, a piece of the syringe snapped off? stated, was not able to use medication that was drawn up and as a result, he had to pay out of pocket for more medication for his wife." "product number 309580.He stated he administers the medication to his wife, and in this particular incident, he stated the needle bent and got separated from the plunger resulting in the medication leaking out and his wife not getting the full amount she needed.Lot number is unknown and the date of event he provided is 12/19/19.".
Additional Manufacturer Narrative
H.6.Investigation: one loose 3ml syringe and one loose, shielded needle were received and evaluated.It was observed there was yellow liquid droplets inside the syringe and needle assembly and no visual defects were present.The cannula appeared to be securely attached to the hub and no deformations were present on the collar of the syringe.The reported defect was not identified in the samples received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

• Brand Name: BD LUER-LOK SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9776124
• Report Number: 1213809-2020-00154
• Device Sequence Number: 11523358
• Product Code: FMF
• UDI-Device Identifier: 30382903095804
• UDI-Public: 30382903095804
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 309580
• Device Catalogue Number: 309580
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other