MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 60ML E/T; PISTON SYRINGE

Catalog Number	300866
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd syringe 60ml e/t, the device experienced a broken barrel.The following information was provided by the initial reporter.The customer stated: broken barrel.
Additional Manufacturer Narrative
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: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-mar-07 h6: investigation summary one photo and one physical sample was provided to our quality team for investigation.Through visual inspection, the tip of the syringe is observed to be incorrectly molded, the tip noted to be damaged causing it to be obstructed.A device history review was performed for the reported lot 2105010, finding one annotation related to the reported event.During the molding process, an issue was identified with the pin that is used to help shape the syringe tip resulting in the pin being removed.Issues with this pin not operating properly can therefore lead to the syringe being molded with defects within the tip as observed in the sample and photo that was provided.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 our investigation, it was determined this incident was likely related to the pin that malfunctioned during the molding process.
Event or Problem Description
It was reported when using the bd syringe 60ml e/t, the device experienced a broken barrel.The following information was provided by the initial reporter.The customer stated: broken barrel.

• Brand Name: BD SYRINGE 60ML E/T
• 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: 13636576
• Report Number: 3003152976-2022-00084
• Device Sequence Number: 11309463
• 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): 03/10/2022

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: 04/30/2026
• Device Catalogue Number: 300866
• Device Lot Number: 2105010
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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