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

Catalog Number	309574
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2021
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 22x1-1/2 rb was damaged.The following information was provided by the initial reporter: material no: 309574, batch no: 0364901.It was reported the cover and the nipple in the luer-lock are warped.Needle also bent.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1-1/2 rb was damaged.The following information was provided by the initial reporter: material no: 309574 batch no: 0364901.It was reported the cover and the nipple in the luer-lock are warped.Needle also bent.
Additional Manufacturer Narrative
H6: investigation summary: two photos and six loose 3ml syringes (p/n 309574) with needles were received.The samples were visually evaluated.All samples had visible crooked shields and bent luer tips.The crookedness in the shields corresponded with the direction of the bent luer tips.One sample also had three small knicks on its shield in line with the epoxy at the base of the needle.Additionally, one needle's hub was also visibly bent.As part of this investigation a process engineer was interviewed and the current process was evaluated to verify that the observed defect was not present.Potential root cause for the bent shield defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Batch 0364901 is considered in compliance with our product specification requirements.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.H3 other text : see h10.

• Brand Name: SYRINGE 3ML LL W/NDL 22X1-1/2 RB
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11868125
• Report Number: 1213809-2021-00365
• Device Sequence Number: 19626213
• Product Code: FMF
• UDI-Device Identifier: 00382903095742
• UDI-Public: 00382903095742
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 06/03/2021

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: 0364901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/22/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1