MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 30ML LL; SYRINGE, PISTON

Catalog Number 301229

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

Syringe cannot be used to draw up medication, no damage caused.Rubber not properly attached to the plunger in the syringe.Syringe is unusable when did the incident occur? during use.

Manufacturer Narrative

(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.

Manufacturer Narrative

One sample and photo received for investigation.Through visual inspection, stopper of the syringe is incorrectly assembled.No molding or other defects have been noticed.A device history review was performed for lot 2309029, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Possible root cause of the non-conformance is related with a misalignment of plunger-stopper-barrel in the assembly station.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.

Event Description

No additional information.

• Brand Name: SYRINGE 30ML LL
• Type of Device: 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 IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18389187
• MDR Text Key: 331494077
• Report Number: 3003152976-2023-00551
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903012299
• UDI-Public: (01)00382903012299
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301229
• Device Lot Number: 2309029
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1