MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ADAPTER WITH LUER ADAPTER; BLOOD COLLECTION SET

Catalog Number 367300

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2018

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 the bd vacutainer® adapter with leur adapter had a hole in the tip of the shield.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Bd received samples and photos from the customer facility for investigation.The photos were evaluated and a hole in the top of the iv shield with the incident lot was observed.Additionally, evaluation of the customer samples was performed and a hole in the top of the iv shield was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer photos and samples, the customer¿s indicated failure mode for a hole in the top of the iv shield with the incident lot was observed.Based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® ADAPTER WITH LUER ADAPTER
• Type of Device: BLOOD COLLECTION SET
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7331927
• MDR Text Key: 102317132
• Report Number: 1024879-2018-00081
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K921520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 367300
• Device Lot Number: 7139695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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
• Patient Outcome(s): Other