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

Catalog Number	300613
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Description/event details: flashes and foreign materials were discovered contrary to the agreed upon requirement and detailed in the drawing.During regular inspection, 3 lot# were checked and flashes and foreign materials were discovered contrary to the agreed upon requirement and detailed in the drawing.As a result, all the batches listed below were rejected.And the complaint is for all 3 lot# : 2401017, 2401020, 2401086.Additional information the foreign material is emended with the device.When did the incident occur? before use.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.Three batch numbers provided: batch: 2401017 batch creation date: 2024-01-02 batch expiration date: 2028-12-31 full udi: (b)(4).Batch: 2401020 batch creation date: 2024-01-02 batch expiration date: 2028-12-31 full udi: (b)(4).Batch: 2401086 batch creation date: 2024-01-02 batch expiration date: 2028-12-31 full udi: (b)(4).
Additional Manufacturer Narrative
(b)(6).Follow up mdr for device evaluation: six samples from lot 2401017, eight from lot 2401086, and seven from lot 2401020 were provided to our quality team for investigation.Through visual inspection, burrs and bubbles within the plastic of the tip were observed on several of the samples, verifying the reported incident.A device history review was performed for reported lots 2401017, 2401086, and 2401020, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Bubbles can occur due to a lack of compaction during the molding process, causing the material not spread completely, creating the bubble as observed in the samples provided.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, including inspections throughout the molding process to verify the product is free from bubbles, scratches, burrs, and other molding issues.Inspection results were reviewed for the reported lot and no issues were identified.Retained samples of each reported lot were used for additional evaluation.All product was inspected and no burrs or bubbles were identified on any of the products.While we could not identify a direct issue, we can confirm both the burrs and bubbles within the tip generated during the molding process.To date, there have been no other similar events reported for these lots.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Description/event details: flashes and foreign materials were discovered contrary to the agreed upon requirement and detailed in the drawing.During regular inspection, 3 lot# were checked and flashes and foreign materials were discovered contrary to the agreed upon requirement and detailed in the drawing.As a result, all the batches listed below were rejected.And the complaint is for all 3 lot# : 2401017.2401020.2401086.Additional information the foreign material is emended with the device.When did the incident occur? before use per response: the foreign material is emended with the device.

• 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: 21468859
• Report Number: 3003152976-2025-00067
• Device Sequence Number: 9182239
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: (01)00382903006137(11)240115(17)281231(10)2401086
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 04/09/2025

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: 300613
• Device Lot Number: MULTIPLE LOT #-SEE H TAB
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown