MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML S/T 200 S/C; PISTON SYRINGE

Catalog Number	303134
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 303134, lot: 3082577.It was reported that the bd syringe 10ml s/t 200 s/c had a scale marking issue.The following information was provided by the initial reporter: rcc received a complaint via email.Bd 10ml syringe slip tip embout luer-slip (ref: 303134, lot: 3082577, exp 2028-02-29).On (b)(6) 2025, one (#1) x 10ml syringe slip tip embout luer-slip had double imprints for numbers and marked increments.No patient harm.Syringe issue was escalated and removed from iv complex.Sample available for return by customer for further investigation.
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 - scale marking issue.One sample and four photos were provided to our quality team for investigation.Through visual inspection, it was observed that syringe has double print on the entire scale markings in the barrel.The condition observed is non-conforming per product specification.The potential root cause for the double print defect is associated with the marking 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 3082577.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 S/T 200 S/C
• 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: 21300307
• Report Number: 1213809-2025-00066
• Device Sequence Number: 8169470
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: (01)00382903031344(11)230323(17)280229(10)3082577
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 03/08/2025

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: 303134
• Device Lot Number: 3082577
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 03/08/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown