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

Catalog Number	364316
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D4.Medical device lot#: unknown d4.Medical device expiration date: unknown e.1.Initial reporter facility name: (b)(6) hospital, local independent administrative agency h4.Device manufacture date: unknown h.6.Investigation summary: material #:364316 lot/batch #: unknown bd had not received samples, but 6 photos were provided for investigation.The photos were reviewed and the indicated failure mode for blood leakage was observed.Bd was unable to determine the specific lot number associated with this complaint so retained sample couldn't be tested.This complaint has been confirmed for the indicated failure mode of leakage.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that while using bd preset¿, blood leaked into the outer sleeve.No patient impact 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: 18624550
• Report Number: 9617032-2024-00122
• Device Sequence Number: 15330748
• Product Code: JKA
• UDI-Device Identifier: 50382903643160
• UDI-Public: (01)50382903643160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/30/2024

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 Catalogue Number: 364316
• Device Lot Number: UNKNOWN
• 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: 01/15/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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