MAUDE Adverse Event Report: BECTON DICKINSON BD PLASTIPAK 10 ML MEDICINE SYRINGE; 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
Event or Problem Description
It was reported that the bd plastipak 10 ml medicine syringe had an issue with volumetric accuracy.The following information was provided by the initial reporter: braun syringe pump did not empty the syringe of medication completely.When the braun syringe pump alarms to indicate that the infusion has started, it appears that approximately 0.5 ml is missing from the syringe.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.There was still 0.4 ml left in the pump.We subsequently visited the medical technical department, who attempted to calibrate the pumps, but this did not help to empty the syringes completely; the same thing happened.We tried with a braun 10 ml syringe and did not encounter the problem.Consequences were avoided because action was taken.
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.
Additional Manufacturer Narrative
As no physical or picture sample, or valid 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 product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.
Additional Manufacturer Narrative
Additional information: (d) updated device material # and lot details; added 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.
Event or Problem Description
No additional information.

• Brand Name: BD PLASTIPAK 10 ML MEDICINE SYRINGE
• 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: 22846338
• Report Number: 2243072-2025-01033
• Device Sequence Number: 19920921
• 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: 08/24/2025; 11/06/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/15/2025; 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