MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367300

Device Problem Break (1069)

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

Event Date 03/06/2023

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 that during use with bd vacutainer® multiple sample luer adapter it was discovered to be cracked.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, the product was found to be chipped during use.

Event Description

It was reported that during use with bd vacutainer® multiple sample luer adapter it was discovered to be cracked.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, the product was found to be chipped during use.

Manufacturer Narrative

H.6.Investigation summary: bd received 1 sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for damaged hub with the incident lot was observed.Additionally, 10 retention samples from bd inventory were evaluated by torque testing to break the hub and the issue of damaged hub was not observed as all samples broke above the specification minimum.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 damaged hub.Bd was not able to identify a root cause for the indicated failure mode.The following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: (b)(4).

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16632936
• MDR Text Key: 312410716
• Report Number: 1024879-2023-00172
• 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: 06/20/2023

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: 367300
• Device Lot Number: 2229779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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