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

Catalog Number	364416
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional lot number reported: d4.Medical device lot#: 4151988.D4.Medical device expiration date: 05-31-2026.D4.Unique identifier (udi) #: (b)(4).H4.Device manufacture date: 05-30-2024.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported after drawing a blood sample with a bd preset¿ syringe the cap was loose causing blood to leak.Blood got on the gloves of the lab technician.This occurred with an unspecified number of syringes.There was no report of adverse impact to patients or users.
Event or Problem Description
It was reported after drawing a blood sample with a bd preset¿ syringe the cap was loose causing blood to leak.Blood got on the gloves of the lab technician.This occurred with an unspecified number of syringes.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
The following fields have been updated with additional information.D9: device available for evaluation: yes d9: returned to manufacturer on: 02-dec-2024 investigation summary: material #: 364416 lot/batch #: 4151988 and 4187145 bd received 2 samples (one from each reported lot number) for investigation.The samples were evaluated by functional testing and the indicated failure mode for leakage from tip cap with the incident lot was not observed.Additionally, 18 retention samples from bd inventory (9 from each reported lot number) were evaluated by functional testing and no issues were observed relating to leakage from tip cap 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 leakage from tip cap.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.

• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20786328
• Report Number: 9617032-2024-01862
• Device Sequence Number: 12510035
• Product Code: JKA
• UDI-Device Identifier: 50382903644167
• UDI-Public: (01)50382903644167(11)240705(17)260630(10)4187145
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 06/30/2026
• Device Catalogue Number: 364416
• Device Lot Number: 4187145
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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