MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1-1/2 RB; PISTON SYRINGE

Catalog Number	309574
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: two photos of a 3ml syringe package confirmed to be from batch 0339480 (p/n 309574) were received and evaluated.Both photos showed the graphic side of the package.Further evaluation could not be performed because the syringe was not visible in the photos.Furthermore, 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.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: during manufacture of this product torque removal testing is performed to ensure needles are properly attached and within specification.It is possible that packaged product is introduced to conditions that could affect the connection after leaving the plant.A physical sample would allow for testing to be performed to confirm if any manufacturing defects are present.The user should also verify a proper connection before using the device.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1-1/2 rb needle was loose.The following information was provided by the initial reporter: material no: 309574 batch no: 0339480.It was reported the needle is attached to the syringe, but not tightly.Verbatim: when the clinician opens the product the needle is attached to the syringe, but not tightly.As a result, there is slight leakage during the reconstitution of the pfizer covid vaccine.After experiencing this issue multiple times, the clinician made the comment that, with this bd product, he now manually tightens the needle on each unit prior to use.Loss of diluent/drug.Extra step now required to assure needle is tightly attached to syringe.

• Brand Name: SYRINGE 3ML LL W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11855925
• Report Number: 1213809-2021-00352
• Device Sequence Number: 4016663
• Product Code: FMF
• UDI-Device Identifier: 00382903095742
• UDI-Public: 00382903095742
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 11/30/2025
• Device Catalogue Number: 309574
• Device Lot Number: 0339480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1