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

Catalog Number 364314

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Event Description

It was reported that while using bd preset¿ arterial blood collection syringe, the blood collection device did not have negative pressure and failed to collect blood.This caused a second blood collection for the patient and event occurred 1 time.The following information was provided by the initial reporter: on (b)(6) 2023, a nurse on the day and night shift, performed arterial blood collection for a patient on bed +36.The blood collection device did not have negative pressure and failed to collect blood.This caused a second blood collection for the patient and promptly replaced it and apologized to the patient.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: 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 insufficient flow 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 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.".

Event Description

It was reported that while using bd preset¿ arterial blood collection syringe, the blood collection device did not have negative pressure and failed to collect blood.This caused a second blood collection for the patient and event occurred 1 time.The following information was provided by the initial reporter: on (b)(6) 2023, a nurse on the day and night shift, performed arterial blood collection for a patient on bed +36.The blood collection device did not have negative pressure and failed to collect blood.This caused a second blood collection for the patient and promptly replaced it and apologized to the patient.

• Brand Name: BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
• Type of Device: 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: 18074231
• MDR Text Key: 327416093
• Report Number: 9617032-2023-01587
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903643146
• UDI-Public: (01)50382903643146
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 364314
• Device Lot Number: 2350187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1