MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 22X3/4 RB; PISTON SYRINGE

Catalog Number	309569
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe¿ 3ml ll w/ndl 22x3/4 rb leaked past the stopper when drawing up medication.Noticed before use.
Additional Manufacturer Narrative
Investigation summary: three 100-count boxes and three loose 3ml syringes with needles taped to an opened blister pack (p/n 309569) were received and visually evaluated.Two of the boxes were confirmed to be from batch #8313764 and one box was confirmed to be form batch #8329966.The blister pack was from batch #8329966.It was observed the three loose syringes contained no residue and did not appear to have any visual defects.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.Leakage test was performed on all the boxed samples with two syringes identified to have a leakage past stopper defect.These samples were visually inspected, and a small consistent deformation was observed in both samples approximately 0.25¿ in length near the 3ml mark inside the grad lines as well as a small scratch in the flange.During this test, it was also observed that three syringes had a twisted hub defect.Potential root cause for the leakage past stopper defect is the result of a damaged barrel.During the assembly process, barrels are individually loaded with a dial and can become jammed which can cause a deformation.Potential root cause for the twisted hub defect is associated with the assembly process.When the needle hub is attached to the syringe it is twisted on.If the machine isn¿t properly adjusted to the correct torque setting overtightening can occur.Based on this sampling and this being the only complaint related to this batch no corrective actions are necessary.Lot 8329966 is considered in compliance with our product specification requirements.No corrective actions are necessary based on the defective rate identified.Lot 8313764 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that bd syringe¿ 3ml ll w/ndl 22x3/4 rb leaked past the stopper when drawing up medication.Noticed before use.

• Brand Name: BD SYRINGE 3ML LL W/NDL 22X3/4 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8396379
• Report Number: 1213809-2019-00304
• Device Sequence Number: 13550469
• Product Code: FMF
• UDI-Device Identifier: 00382903095698
• UDI-Public: 00382903095698
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 309569
• Device Lot Number: 8313764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other