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

Catalog Number 364356

Device Problem Illegible Information (4050)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).H.6.Investigation summary: material #: 364356 lot/batch #: 3087296 bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for defective scale markings was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of defective scale markings 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 defective scale markings.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported that prior to use of bd a-line¿, the scale was distorted.No patient impact reported.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19069673
• MDR Text Key: 339678598
• Report Number: 9617032-2024-00525
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903643566
• UDI-Public: (01)50382903643566
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022426
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364356
• Device Lot Number: 3087296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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