MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1 RB; PISTON SYRINGE

Catalog Number	309572
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1 rb had an improper seal.The following information was provided by the initial reporter: it was reported that several syringes that have not had an adequate seal.Verbatim: we have had several syringes that have not had an adequate seal.This has caused issues drawing patient doses, as well as administering patient doses.One of our end users reported that the dose leaked out of the syringe due to improper seal.
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.No root cause can be determined as no samples were received.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.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1 rb had an improper seal.The following information was provided by the initial reporter: it was reported that several syringes that have not had an adequate seal.Verbatim: we have had several syringes that have not had an adequate seal.This has caused issues drawing patient doses, as well as administering patient doses.One of our end users reported that the dose leaked out of the syringe due to improper seal.

• Brand Name: SYRINGE 3ML LL W/NDL 22X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12302862
• Report Number: 1213809-2021-00553
• Device Sequence Number: 3718626
• Product Code: FMF
• UDI-Device Identifier: 00382903095728
• UDI-Public: 00382903095728
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/13/2021

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: 12/31/2025
• Device Catalogue Number: 309572
• Device Lot Number: 1012676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1