MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 25X1-1/2 RB; PISTON SYRINGE

Model Number	309582
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the plunger rod was incorrectly positioned "at the top" of the syringe 3ml ll w/ndl 25x1-1/2 rb before use.The following information was provided by the initial reporter: "consumer stated the plungers were all rested at the top of syringe and never saw this before." "consumer just purchased this box and is finding the plunger stopper to not had a gap to the top of syringe.".
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.Based on information received from manufacturing, the customer's complaint is a design issue.The product is designed exactly the way the customer explained it and there is no defect.The stoppers are all in the correct position as per manufacturing.
Event or Problem Description
It was reported that the plunger rod was incorrectly positioned "at the top" of the syringe 3ml ll w/ndl 25x1-1/2 rb before use.The following information was provided by the initial reporter: "consumer stated the plungers were all rested at the top of syringe and never saw this before." "consumer just purchased this box and is finding the plunger stopper to not had a gap to the top of syringe".

• Brand Name: SYRINGE 3ML LL W/NDL 25X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9662403
• Report Number: 1213809-2020-00043
• Device Sequence Number: 16315775
• Product Code: FMF
• UDI-Device Identifier: 30382903095828
• UDI-Public: 30382903095828
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/04/2020

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 Expiration Date: 04/30/2024
• Device Model Number: 309582
• Device Catalogue Number: 309582
• Device Lot Number: 9127967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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