MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS PLASTIPAK LUER-LOK; PISTON SYRINGE

Catalog Number	309658
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
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
It was reported that bd syringe 3ml ll euro 200 s/c barrel was cracked.Verbatim: the preparer, while preparing a chemotherapy bag, used a 3ml syringe that was cracked.Thus, when withdrawing a volume from the bag, the contents spilled into the isolator.The syringe was set aside to be given to materials vigilance.This incident was not serious because no chemotherapy had yet been added to the bag (no cytotoxic contamination).
Additional Manufacturer Narrative
(b)(4) supplemental mdr - barrel cracked.One fully assembled loose syringe (part number 309658) was received and evaluated.During inspection, a severe crack was observed extending from near the bottom of the barrel to close to the top.This condition is non conforming to the product specification, and the cracked barrel is potentially attributable to the assembly process.Furthermore, a device history record review was completed for the provided lot number 5237660.The review showed no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints received for this device and the reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly.The business team regularly reviews the collected data to identify emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: PLASTIPAK LUER-LOK
• 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: 24407901
• Report Number: 1213809-2026-00088
• Device Sequence Number: 12818027
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589(10)5237660
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 309658
• Device Lot Number: 5237660
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown