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

Catalog Number	300912
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3.Franklin lakes has been listed as the manufacturer.G.1.Franklin lakes has been listed as the manufacturer.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 the bd syringe had an issue with volumetric accuracy.The following information was provided by the initial reporter: braun syringe pump does not empty the entire syringe of medicine when the braun syringe pump alarms that the infusion (dose in the syringe) has been administered, it turns out that 0.7-0.8 ml is missing from the syringe.It must be administered at a specific and consistent speed.It must also be administered by pump because elevated pressure can be monitored during administration.We had to reset the pump several times so that more of the medicine could be administered, but eventually the pump indicated that the arm had reached its end position.At this point, there was still 0.45 ml left in the pump.They are called bd plastic packs.They are manufactured in the usa and around europe.The syringes have slight differences depending on where they were manufactured, which is why this happens.We tried a braun 10 ml syringe and did not encounter this problem.
Additional Manufacturer Narrative
(b)(4) follow up: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
Additional information: syringe 10 ml bd syringe luer-lok tip sterile ref 300912 with lot no.: 1239263 / use by: 31.08.2026.
Additional Manufacturer Narrative
Additional information: (b5) device details provided.(d) added catalog #, lot details, and udi.(g) added 510(k).Investigation results: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.We will continue monitoring the complaint trend for the product and symptom.Batch 1239263 is considered in compliance with our product specification requirements.

• Brand Name: LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22875943
• Report Number: 2243072-2025-01048
• Device Sequence Number: 5689563
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121(11)210827(17)260831(10)1239263
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 300912
• Device Lot Number: 1239263
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 11/06/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 08/27/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown