MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364416
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd preset¿, air bubbles were present in one of the syringes.No patient impact or injury reported.
Additional Manufacturer Narrative
E.1.Initial reporter addr 1: (b)(6) h.6 investigation summary: material #: 364416 lot/batch #: 2152474 bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to air bubbles as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode air bubbles.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Additional Manufacturer Narrative
H.6 investigation summary.Material #: 364416.Lot/batch #: 2152474.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for air bubbles was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and the issue of air bubbles was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode air bubbles.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported that when using the bd preset¿, air bubbles were present in one of the syringes.No patient impact or injury reported.

• Brand Name: BD PRESET¿
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18614850
• Report Number: 9617032-2024-00105
• Device Sequence Number: 7565204
• Product Code: JKA
• UDI-Device Identifier: 50382903644167
• UDI-Public: (01)50382903644167
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K022426
• 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): 02/22/2024

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: 05/31/2024
• Device Catalogue Number: 364416
• Device Lot Number: 2152474
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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