MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/TWINPAK DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303391
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 3ml ll w/twinpak device barrel cracked.The following information was provided by the initial reporter: material # 303391 lot # 4326390.  verbatim: rcc received a complaint via email.Email(s) attached.Product code sku:0723303391 product description brand name:syringe combo 3 cc twin pak when problem was notice: during use sterilization wrap: incident discovered during patient care:yes nature of patient care:unknown quantity: (b)(4).Uom: box 2 lot: 4326390 date of event: 4/1/2025 12:00:00 am incident details: syringe is cracked.Leaking while in use.No noticeable damage to the package.Was patient or end-user injured: no injury details: was medical treatment required:no treatment details: patient current status: unknown has the facility filed a report with health authority(ies)?: no is photo available: yes attach photo: twinpak.Jpg is sample available:yes sample used/unused: unused.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - barrel cracked.Three samples and one photo were provided to our quality team for investigation.One syringe exhibited a crack extending the full length of the barrel through to the inner wall, resulting in leakage.The other two samples had barrel cracks measuring approximately ¼ inch and ½ inch, respectively, though these did not extend completely through the wall.The condition observed is non-conforming per product specification.Potential root cause for the barrel cracked and leakage defects is associated with the assembly process.Furthermore, a device history record review was completed for provided lot number 4326390.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/TWINPAK DEVICE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 21896328
• Report Number: 1213809-2025-00299
• Device Sequence Number: 16995575
• Product Code: FMI
• UDI-Device Identifier: 00382903033911
• UDI-Public: (01)00382903033911(10)4326390
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• 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): 06/13/2025

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 Catalogue Number: 303391
• Device Lot Number: 4326390
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown