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

Model Number	300613
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter address 1: (b)(6).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 plastipak¿ luer-lok¿ syringe leaked past the stopper.The following information was provided by the initial reporter, translated from (b)(6) to english: when drawing propofol from a 20ml ampoule with a 20ml syringe, some of the drug ran down the plunger of the syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 06-jun-2022.H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, a leakage past the stopper ribs was observed.The product was further inspected, there was no visible damage or other defect that could have contributed to the leakage and the stopper was verified to be properly assembled on to the plunger rod.A device history review was performed for the reported lot 1711310, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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 leakage testing.Results were reviewed for the reported lot and no issues were identified.Based on our investigation, we cannot identify a definitive root cause at this time.
Event or Problem Description
It was reported that the bd plastipak¿ luer-lok¿ syringe leaked past the stopper.The following information was provided by the initial reporter, translated from french to english: when drawing propofol from a 20ml ampoule with a 20ml syringe, some of the drug ran down the plunger of the syringe.

• 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: 14564432
• Report Number: 3003152976-2022-00239
• Device Sequence Number: 5900971
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/06/2022

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 Expiration Date: 10/31/2022
• Device Model Number: 300613
• Device Catalogue Number: 300613
• Device Lot Number: 1711310
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2017
• 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