MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 60ML E/T; SYRINGE, PISTON

Catalog Number	305891
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: unknown, batch number#: 2202004.It was reported by customer that when using the product with vaccines in glass prefilled syringes we have found that these needles don¿t work due to the amount of pressure needed to twist the tip on the luer lock system.What happens is that the glass prefilled syringes have a luer lock adapter that breaks off when trying to use these needle tips due to the pressure needed to secure the needle tip to the barrel.I was wondering if you still offer 1¿ needle tips of the same style without the smart slip for this purpose.We first discovered the issue on (b)(6) 2024 and the product number is# 305891.We wasted multiple doses of vaccine in prefilled syringes on this date and also had a situation (on the same day) in which a prefilled syringe looked fine but actually leaked fluid during administration of the vaccine onto the skin (thus client did not receive a full dose as intended).I suspect that the luer lock piece on the vial might have partially disconnected when putting on the needle tip and thus that allowed leakage-although this was not something that you could see by looking at it.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Follow up mdr for correction.Following the submission of the initial mdr, the material number was updated and it was determined that the site legal name and site registration number were incorrect.A new initial mdr will be submitted with the correct information.This mdr will be void.

• Brand Name: SYRINGE 60ML E/T
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19200958
• Report Number: 3003152976-2024-00254
• Device Sequence Number: 7997086
• Product Code: FMI
• UDI-Device Identifier: 50382903058919
• UDI-Public: (01)50382903058919
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: Health Professional
• Device Catalogue Number: 305891
• Device Lot Number: 2202004
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown