MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; SYRINGE, ANTISTICK

Catalog Number	305905
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material #: 305905.Batch#: 0199965.It was reported that the bd syringe 3ml ll w/ndl sftygld 23x1 rb had leakage.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Item: 305905.Quantity affected: 2 bx.Serial/lot number: (b)(6).Po : (b)(4).Are any samples available for return? yes.Reported issue: syringes leaking.Additional information provided: 1.Could you please provide a further description of the issue? the ma administered a testosterone injection and the patient did not receive his full dose since it was leaking on the sides inside of the syringe 2.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? after the injection was administered the ma noticed testosterone leaking inside of the syringe.3.Can you please provide an exact date of event in format dd-mmm-yyyy? 4.What was the medication/fluid in use at the time of the event? testosterone cypionate.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Twenty-eight samples from batch 0199965 were provided to our quality team for investigation.All samples were tested for leakage at luer tip and leakage past stopper.One sample was found to leak past the stopper.The condition observed is non-conforming per product specification.Potential root cause for the leakage past stopper defect is associated with the assembly process.These conditions are occurring below their expected frequency.Therefore, no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 0199965.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• Common Device Name: SYRINGE, ANTISTICK
• 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: 20846973
• Report Number: 1213809-2024-00919
• Device Sequence Number: 8152479
• Product Code: MEG
• UDI-Device Identifier: 30382903059059
• UDI-Public: (01)30382903059059(11)200717(17)250630(10)0199965
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 01/31/2025

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 Expiration Date: 06/30/2025
• Device Catalogue Number: 305905
• Device Lot Number: 0199965
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown