MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL W/NDL 21X1-1/2 RB; PISTON SYRINGE

Catalog Number	309633
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2020
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 2 syringes 5ml ll w/ndl 21x1-1/2 rb experienced a broken needle.The following information was provided by the initial reporter: material no:309633, batch no:0224356.Customer e-mailed a photo of two broken needles.
Event or Problem Description
It was reported that 2 syringes 5ml ll w/ndl 21x1-1/2 rb experienced a broken needle.The following information was provided by the initial reporter: material no:309633, batch no:0224356.Customer e-mailed a photo of two broken needles.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received and evaluated.Two assembled 5ml syringes with needles were observed in the photos, as well as a portion of a blisterpack¿s top web depicting batch #0224356 (p/n 309633).The two needles attached to the two syringes had twisted hub condition, with one of these two needles completely twisted off remaining inside the shield.Potential root cause for the twisted hub defect is associated with the assembly process.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 21X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11181371
• Report Number: 1213809-2021-00022
• Device Sequence Number: 2210733
• Product Code: FMF
• UDI-Device Identifier: 00382903096336
• UDI-Public: 00382903096336
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 07/31/2025
• Device Catalogue Number: 309633
• Device Lot Number: 0224356
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1