MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Catalog Number	305060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material# 305060 batch# 3319595 it was reported that the bd syringe 3ml ll w/ndl 18x1-1/2 blunt fill had leakage past the stopper.The following information was provided by the initial reporter: verbatim: medication was actually drawn into the syringe and bypassed the rubber stopper and lack of suction when drawing labs.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation.Two samples were provided to our quality team for investigation.Through visual inspection, it was observed that one syringe has barrel damaged in two places with an actual puncture mark through the barrel and the plunger rod was also damaged in two places which cause leakage.No defect was observed on another sample.Potential root cause for the damaged barrel, plunger and leakage past stopper defects is associated with the assembly process.These defects are occurring below an expected rate so no corrective actions will be made at this time.Furthermore, a device history record review was completed for provided lot number 3319595.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19975794
• Report Number: 1213809-2024-00539
• Device Sequence Number: 12534395
• Product Code: FMF
• UDI-Device Identifier: 30382903050605
• UDI-Public: (01)30382903050605(11)231115(17)281031(10)3319595
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 305060
• Device Lot Number: 3319595
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown