MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE WITH LUER-LOK TIP WITH BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303347
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/15/2020
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 bd 10ml syringe with luer-lok tip with blunt plastic cannula.The following information was provided by the initial reporter: when unpacking, the hcp found that the tip of the syringe (blunt cannula/vial access component) was damaged.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 11/19/2020.H.6.Investigation: two 5ml syringes with blunt fill needles attached were received and evaluated.One was in a fully sealed blister pack from batch 9095641 (p/n 303347) and one was loose.It was observed, the loose syringe had a bent tip and a slightly deformed collar, which was rejectable per product specification.No defects were observed with the syringe in the package.Potential root cause for the tip damage defect is likely associated with the assembly process.Batch 9095641 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.
Event or Problem Description
It was reported that the bd 10ml syringe with luer-lok tip with blunt plastic cannula.The following information was provided by the initial reporter: when unpacking, the hcp found that the tip of the syringe (blunt cannula/vial access component) was damaged.

• Brand Name: BD 10ML SYRINGE WITH LUER-LOK TIP WITH BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10796068
• Report Number: 1213809-2020-00776
• Device Sequence Number: 14075188
• Product Code: FMI
• UDI-Device Identifier: 30382903033479
• UDI-Public: 30382903033479
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 03/31/2024
• Device Model Number: 303347
• Device Catalogue Number: 303347
• Device Lot Number: 9095641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1