MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 20ML E/T; SYRINGE, PISTON

Catalog Number	300613
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Seal on the plunger has a piece of rubber on it.Additional information from customer: the piece of rubber is attached to the stopper.
Additional Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: two photos and one physical sample were provided to our quality team for investigation.Through visual inspection, a black piece which corresponds to the stopper, was observed within the syringe.A device history review was performed for the reported lot 2312046, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.The stopper is provided by an external supplier.Incoming inspections are performed according to procedure, including verification the stoppers are complete and not deformed.The quality certificate was reviewed for the stopper batches used with syringes from lot 2312046, no issues were identified.Retained samples of the reported lot were used for additional evaluation.All stoppers were inspected and no damage or other defects were observed on any of the devices.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, no issues related to the reported incident were found.Based on the sample evaluation, it is believed this incident is related to an issue during the stopper manufacturing.We have notified the supplier of this incident.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE 20ML E/T
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18958394
• Report Number: 3003152976-2024-00182
• Device Sequence Number: 4580109
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: (01)30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/09/2024

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: 300613
• Device Lot Number: 2312046
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown