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

Catalog Number	309571
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl 23x1 rb had a syringe needle connectivity issue.Rcc received a complaint via email.I would like to report that several anomalies were found in the 3cc syringes from lot: 5276052, expiry date: 30 september 2030.It had been noted that some 3cc syringes from the lot: 5276052 did not screw on properly or had certain anomalies (needle without bevel, bent needle, etc.).These findings were under investigation when this event occurred.We would like to discuss with you possible recent changes in the manufacturing process for 3cc syringes.Additional information was received on 02/09/2026: 1.Could you provide us with the exact date of the incident in mm-dd-yyyy format? our first cases started at the beginning of november, unfortunately i do not have an exact date; but my team finds samples that are not compliant within 2-3 days.2.Did this event result in any damage, injury, complication or negative consequences for the patient? no, the syringes are thrown away, they were not sent to our clients when anomalies are detected.3.Is a physical sample of the product presenting the reported problem available? if yes, please provide us with the address of the establishment so that we can send you a return label.Yes, the needles from the attached photo are available for sending.4.If available, please share the photos or videos of the event.5.Could you please specify if a connection problem was found during use and a leak was observed, or the syringe could not be used because it did not connect properly? connection problem: yes (syringe used after manual reconnection, but we had a complaint regarding 2 syringes whose needles detached from the syringe at the client¿s place, the 2 doses were not used by the client).Leak problem: yes (along the needle, but not at the tip where it attaches to the syringe).Other problems: curved needles, needles with missing piece, etc.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported some 3ml syringes from the lot 5276052 did not screw on properly or had other anomalies.To support the investigation, five samples and one photograph were received by the quality team.All five samples arrived loose, each with a 23 g x1 in needle attached.No syringe defects were observed, and needle attachment was secure across all samples.Each sample underwent leak testing, and no leakage was detected.Four needles were bent, with deformation beginning approximately 0.25 in from the top of the needle hub.The tips of these needles showed no damage, grinding defects, or hooks, and the bevels and etch were acceptable.The remaining sample had a needle with damage located approximately 0.25 in from the top of the hub.No other defects or imperfections were noted.Each sample was assembled with saline solution for functional evaluation, and no leakage was observed.The submitted photograph shows three needles attached to syringes, with two bent and one damaged, consistent with the returned sample condition.The observed condition is nonconforming to the product specification and could occur if a jam occurred at the cannulator.A review of the device history record for material number 309571, lot 5276052, confirmed that all required visual inspections were performed, with no quality notifications related to the reported condition.The lot was inspected and accepted per the inspection control plan and approved for shipment.Additional device histories were reviewed for each lot of needles used in manufacturing the final lot, no documentation of similar conditions was recorded during production.Verification of the cannulator confirmed that the settings were correct and product flow was acceptable.Based on the investigation and analysis of the returned samples, the customer reported symptom is confirmed.

• Brand Name: BD 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: 24329695
• Report Number: 1213809-2026-00062
• Device Sequence Number: 4810997
• Product Code: FMF
• UDI-Device Identifier: 00382903095711
• UDI-Public: (01)00382903095711(11)251003(17)300930(10)5276052
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: Other
• Device Catalogue Number: 309571
• Device Lot Number: 5276052
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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