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

Catalog Number 364378

Device Problem Inaccurate Information (4051)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd a-line¿ syringe w/o needle, customer found luer slip syringe mix with luer-lock syringes carton.The following information was provided by the initial reporter.The customer stated: "this is a report about a mixed product.According to the customer¿s report, one luer slip syringe was found in the luer lock syringe carton.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-01-04.H.6.Investigation summary: bd received 1 sample and 3 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for mixed product was observed as a hemogard cap was observed in the packaging.The customer sample was evaluated by visual examination and the indicated failure mode for mixed product with the incident lot was observed as a hemogard cap was observed in the packaging.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of mixed product 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 mixed product.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd a-line¿ syringe w/o needle, customer found luer slip syringe mix with luer-lock syringes carton.The following information was provided by the initial reporter.The customer stated: "this is a report about a mixed product.According to the customer¿s report, one luer slip syringe was found in the luer lock syringe carton.".

• Brand Name: BD A-LINE¿ SYRINGE W/O NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16051744
• MDR Text Key: 308444579
• Report Number: 9617032-2022-01325
• Device Sequence Number: 1
• Product Code: JKA
• 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,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 364378
• Device Lot Number: 1299100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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