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

Catalog Number	300613
Medical Device Problem Code	Material Separation (1562)
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
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¿ syringe stopper separated from the plunger during product sampling.The following information was provided by the initial reporter, translated from french: "the rubber part came off during a product sampling.Occurred in our radiology unit.The rubber part came off during a product sampling.".
Event or Problem Description
It was reported that the bd plastipak¿ syringe stopper separated from the plunger during product sampling.The following information was provided by the initial reporter, translated from french: "the rubber part came off during a product sampling.Occurred in our radiology unit.The rubber part came off during a product sampling.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 02-jan-2023.H6: investigation summary: one sample was provided to our quality team for investigation.The product was visually inspected and the stopper was verified to be incorrectly assembled.A device history review was performed for lot 2207134, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.

• Brand Name: BD PLASTIPAK¿ 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: 16007797
• Report Number: 3003152976-2022-00570
• Device Sequence Number: 5511101
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: 00382903006137
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 300613
• Device Lot Number: 2207134
• 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: 01/18/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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