MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LUER-LOK GAMMA IRRADIATED; PISTON SYRINGE

Model Number	304406
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
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.(b)(4).
Event or Problem Description
It was reported that syringe 10ml luer-lok gamma irradiated leaked.The following information was provided by the initial reporter: "material no.: 304406, batch no.: 8324556.It was reported that multiple cracks at the luer lock area of the syringe which lead to leaking.Crack- leak.Customer report of "leaking" was confirmed.Leakage was detected at the tip of the coset syringe during priming.Multiple cracks were observed at the luer lock area of the syringe.The crack also extended to the syringe barrel, approximately 0.55" in length.Leakage occurred from the crack on syringe barrel.No other visible damage was observed from the coset system.Engineering task assigned for further investigation.".
Additional Manufacturer Narrative
H.6.Investigation: two photos of a loose 10ml syringe were received and evaluated.It was observed in both photos the syringe had crack around the base of the collar and a crack that extended from the middle of the threads and into barrel to the 1ml marking.The damaged was rejectable per product specification.Potential root cause for the cracked barrel 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.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 10ml luer-lok gamma irradiated leaked.The following information was provided by the initial reporter: "material no.: 304406, batch no.: 8324556.It was reported that multiple cracks at the luer lock area of the syringe which lead to leaking.Crack- leak: customer report of "leaking" was confirmed.Leakage was detected at the tip of the coset syringe during priming.Multiple cracks were observed at the luer lock area of the syringe.The crack also extended to the syringe barrel, approximately 0.55" in length.Leakage occurred from the crack on syringe barrel.No other visible damage was observed from the coset system.Engineering task assigned for further investigation.".

• Brand Name: SYRINGE 10ML LUER-LOK GAMMA IRRADIATED
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11190477
• Report Number: 1213809-2021-00024
• Device Sequence Number: 17128642
• Product Code: FMF
• UDI-Device Identifier: 50382903044066
• UDI-Public: 50382903044066
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (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): 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 Model Number: 304406
• Device Catalogue Number: 304406
• Device Lot Number: 8324556
• 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: 01/18/2021
• 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