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

Catalog Number	364416
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd preset¿ had no blood coming in.The following information was provided by the initial reporter: at hospital when they tried to get a sample with our abg preset 1 ml.The blood was not coming into syringe.Kindly note that they were using bd preset & dispo 26g needle to collect the sample.
Additional Manufacturer Narrative
H3.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 that the bd preset¿ had no blood coming in.The following information was provided by the initial reporter: at hospital when they tried to get a sample with our abg preset 1 ml.The blood was not coming into syringe.Kindly note that they were using bd preset & dispo 26g needle to collect the sample.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for insufficient blood flow 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 insufficient flow 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 insufficient blood flow.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.The following fields have been updated with additional/corrected information: short description: insufficient blood flow through device.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17877799
• Report Number: 9617032-2023-01326
• Device Sequence Number: 12679209
• Product Code: JKA
• UDI-Device Identifier: 50382903644167
• UDI-Public: (01)50382903644167
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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: 09/08/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/23/2023
• 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