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

Model Number	300613
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.Initial reporter name and address: initial reporter facility name: (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 while using the bd¿ plastipak luer slip syringes the plunger is difficult to move.The following information was provided by the initial reporter, translated from french to english translated from french: the syringe is difficult to use, the plunger is difficult to move.The anesthetist had difficulties injecting his products because of the resistance of the piston.
Additional Manufacturer Narrative
H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2205046, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Retained samples from the same lot were used for additional evaluation.The products were visually inspected, no damage or defects were identified and the stoppers were properly assembled on to the plunger rod.The silicone employed in this product is a medial grade and is used during the syringe assembly process to lubricate the cylinders in the silicone station in order to help ease the movement of the plunger.Throughout the manufacturing process, break out force, sustaining force testing, and silicone content tests are conducted for each lot.Results for the reported lot were reviewed and no issues were identified.Testing was also performed on the retained samples and all product was confirmed to be within required specifications.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.Based on the available information, we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that while using the bd¿ plastipak luer slip syringes the plunger is difficult to move.The following information was provided by the initial reporter, translated from french to english translated from french: the syringe is difficult to use, the plunger is difficult to move.The anesthetist had difficulties injecting his products because of the resistance of the piston.

• Brand Name: BD¿ PLASTIPAK LUER SLIP SYRINGES
• 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: 15200486
• Report Number: 3003152976-2022-00363
• Device Sequence Number: 6451263
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/21/2022

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: 2205046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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