MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Model Number	309645
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd 10ml syringe luer-lok¿ tip product leaked out a split/crack on the side of two syringes.The following information was provided by the initial reporter: date: (b)(6) 2022 complaint number: (b)(4).Item number: 308-309645 item description: 10ml ll ster syringe w/ 20gx1.5â¿� ndl reg incident description: as per cs, this customer advised that the below syringes appear to have a split/crack in the sides.When pushing medication through the syringe product leaks out the side.This has happen with 2 different syringes.
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 while using bd 10ml syringe luer-lok¿ tip product leaked out a split/crack on the side of two syringes.The following information was provided by the initial reporter: date: 06/06/2022, complaint number: (b)(4), item number: 308-309645, item description: 10ml ll ster syringe w/ 20gx1.5â¿� ndl reg.Incident description: as per cs, this customer advised that the below syringes appear to have a split/crack in the sides.When pushing medication through the syringe product leaks out the side.This has happen with 2 different syringes.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 27-jun-2022.H6: investigation summary: one sample and two photos of a 10ml luer-lock syringe (p/n 309645) were received and evaluated.The sample has a crack in the barrel measuring 11/8 inch long starting ¼ inch from the roof of the barrel.The condition observed is non-conforming per product specification.Potential root cause for the cracked barrel defect is associated with the assembly process.A device history record review was completed for provided lot number 1113346.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD 10ML SYRINGE LUER-LOK¿ TIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14940728
• Report Number: 1213809-2022-00368
• Device Sequence Number: 19967149
• Product Code: FMF
• UDI-Device Identifier: 30382903096450
• UDI-Public: 30382903096450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 03/31/2026
• Device Model Number: 309645
• Device Catalogue Number: 309645
• Device Lot Number: 1113346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown