MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL W/NDL 21X1 RB; PISTON SYRINGE

Model Number	309632
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl 21x1 rb plunger was seated incorrectly and difficult to move.The following information was provided by the initial reporter: "customer stated that they have had the same issue with two different syringes.Customer stated that the plunger is not seated correctly and that there is an issue with the plunger's circumference.For material 309632, doe (b)(6) 2020.Before use, no adverse events.".
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl 21x1 rb plunger was seated incorrectly and difficult to move.The following information was provided by the initial reporter: "customer stated that they have had the same issue with two different syringes.Customer stated that the plunger is not seated correctly and that there is an issue with the plunger's circumference.For material 309632; doe (b)(6) 2020.Before use, no adverse events.".
Additional Manufacturer Narrative
H.6.Investigation: 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.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.

• Brand Name: SYRINGE 5ML LL W/NDL 21X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10860770
• Report Number: 1213809-2020-00814
• Device Sequence Number: 14535345
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2025
• Device Model Number: 309632
• Device Catalogue Number: 309632
• Device Lot Number: 0092344
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1