MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE

Model Number	300613
Medical Device Problem Codes	Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd plastipak¿ luer-lok¿ syringe had a defective stopper with a string-like piece of foreign matter attached to it.The following information was provided by the initial reporter, translated from (b)(6) "i would like to report a production error with a 20 ml bd syringe with luer.It concerns lotnr 21112036.Hopefully this is a one-off faulty specimen, as it would be unthinkable to inject the particle into a patient.".
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 18-jul-2022.H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, a black plastic-like particle was observed on the stopper of the syringe.A device history review was performed for the reported lot 2112036, no deviations or non-conformances 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.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 available information, a root cause related to our manufacturing process cannot be identified at this time.
Event or Problem Description
It was reported that the bd plastipak¿ luer-lok¿ syringe had a defective stopper with a string-like piece of foreign matter attached to it.The following information was provided by the initial reporter, translated from dutch: "i would like to report a production error with a 20 ml bd syringe with luer.It concerns lotnr 21112036.Hopefully this is a one-off faulty specimen, as it would be unthinkable to inject the particle into a patient.".

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ 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: 13839042
• Report Number: 3003152976-2022-00110
• Device Sequence Number: 991021
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/19/2022

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 Model Number: 300613
• Device Catalogue Number: 300613
• Device Lot Number: 2112036
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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