MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) SYR ABG PRESET 3(1.6) LL 23X1 CE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364327

Device Problem Leak/Splash (1354)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported when using the, syr abg preset 3(1.6) ll 23x1 ce, blood leaked out of the syringe.No patient impact.The following information was provided by the initial reporter: "when the child was given arterial blood gas, it was found that the arterial blood had spread to the lumen through the piston.".

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: material #: 364314.Lot/batch #: 3075469.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 leakage 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.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the, syr abg preset 3(1.6) ll 23x1 ce, blood leaked out of the syringe.No patient impact.The following information was provided by the initial reporter: "when the child was given arterial blood gas, it was found that the arterial blood had spread to the lumen through the piston.".

• Brand Name: SYR ABG PRESET 3(1.6) LL 23X1 CE
• 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: 18147741
• MDR Text Key: 328262670
• Report Number: 9617032-2023-01647
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903643276
• UDI-Public: (01)50382903643276
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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: Other
• Device Catalogue Number: 364327
• Device Lot Number: 3075469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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