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

Catalog Number 364376

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter facility name: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd a-line¿, there is blood splatter and leakage of one cracked tube.No patient impact reported.The following information was provided by the initial reporter: "this report is about abg line cracks.Blood leaked when using the syringe.".

Manufacturer Narrative

Bd received 1 used sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for cracked barrel / leakage with the incident lot was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of cracked barrel 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 cracked barrel / leakage.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.H3 other text : see h.10.

Event Description

It was reported that while using bd a-line¿, there is blood splatter and leakage of one cracked tube.No patient impact reported.The following information was provided by the initial reporter: "this report is about abg line cracks.Blood leaked when using the syringe.".

• Brand Name: BD A-LINE¿
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17865499
• MDR Text Key: 324891721
• Report Number: 9617032-2023-01293
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364376
• Device Lot Number: 2277866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2023
• 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