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

Model Number	300866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
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 when using the bd syringe 60ml device experienced a damaged / broken plunger rod.The following information was provided by the initial reporter.The customer stated: the plunger flange broken.
Event or Problem Description
It was reported when using the bd syringe 60ml device experienced a damaged / broken plunger rod.The following information was provided by the initial reporter.The customer stated: the plunger flange broken.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/9/2021.H.6.Investigation: one sample and photo received for investigation.Upon visual inspection, it can be observed the thumb press of the plunger of the syringe is broken.The broken part was also sent in a bag apart, suggesting the piece was found inside the blister of the device.A device history review was performed for the reported lot 2011701, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Possible root cause is associated with a damage or hit on the plunger during manufacturing process or transport as the broken piece is inside the blister.H3 other text : see h.10.

• 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: 13023472
• Report Number: 3003152976-2021-00831
• Device Sequence Number: 11993504
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• 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): 01/13/2022

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: 10/31/2025
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2011701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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