MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL W/NDL 21X1 RB; PISTON SYRINGE

Catalog Number	309642
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 309642, lot # 4274203.It was reported that the bd syringe 10ml ll w/ndl 21x1 rb barrel cracked.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Complaint#: (b)(4)., (b)(4).Product: bd 10ml luer-lok syringe 21gx1in, product #: 15-9642-0, lot#: 4274203.Complaint: it was reported to xx that there was a crack in the body of the syringe when medication was drawn into the syringe and administered.Fluid leaked from cracked area.Additional information provided: 1.What is the date of event? 1/6/2025.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None 3.Any sample available for investigation? yes, however there is blood in the syringe.If yes, are you able to provide the address of the facility for us to ship the return label? (b)(4).4.Please share the captured photo of the event if available.N/a.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Supplemental mdr - barrel cracked.One sample was provided to our quality team for investigation.Upon inspection, a significant crack was observed extending from around the number 1 to the number 5 in the non-scale marking area.The condition observed is non-conforming per product specification.The potential root cause for the cracked barrel 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 4274203.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 10ML LL W/NDL 21X1 RB
• 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: 21230543
• Report Number: 1213809-2025-00031
• Device Sequence Number: 7475607
• Product Code: FMF
• UDI-Device Identifier: 30382903096429
• UDI-Public: (01)30382903096429(11)240930(17)290831(10)4274203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 309642
• Device Lot Number: 4274203
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown