MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ ECCENTRIC LUER SLIP TIP SYRINGE; PISTON SYRINGE

Catalog Number	300866
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ eccentric luer slip tip syringe stopper peeled off within the barrel.The following information was provided by the initial reporter, translated from mandarin chinese to english: there seems a piece of stopper peeled off within the barrel.
Event or Problem Description
It was reported that the bd¿ eccentric luer slip tip syringe stopper peeled off within the barrel.The following information was provided by the initial reporter, translated from mandarin chinese to english: there seems a piece of stopper peeled off within the barrel.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-jan-2023.H6: investigation summary one physical sample and one photo were provided to our quality team for investigation.Through visual inspection, a black particle was identified inside the syringe.Further evaluation identified the particle was a stopper flap that was detached.A device history review was performed for reported lot 2112098, no deviations or non-conformances related to the reported issues were identified during the manufacturing process that could have contributed to this issue.This component is provided by an external supplier, incoming inspections are performed according to procedure.We have notified the supplier of this incident.Based on the available information, a root cause related to our manufacturing process cannot be identified at this time, therefore it is likely the incident is related to an issue with the material provided by the supplier.

• Brand Name: BD¿ ECCENTRIC LUER SLIP TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16018267
• Report Number: 3003152976-2022-00576
• Device Sequence Number: 6678960
• Product Code: FMF
• UDI-Device Identifier: 00382903008667
• UDI-Public: 00382903008667
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: Other
• Device Catalogue Number: 300866
• Device Lot Number: 2112098
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown