MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE; SYRINGE

Catalog Number 366566

Device Problems Structural Problem (2506); Defective Device (2588)

Patient Problem Pain (1994)

Event Date 01/10/2018

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® sst¿ ii advance had a molding defect (burr) on the bottom of the tube.The nurse reports it was painful to collect blood during use, but did not receive an injury or medical intervention at the time of the event.

Manufacturer Narrative

Investigation results: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for molding defect with the incident lot was observed.Additionally, evaluation of the customer samples was performed and molding defect 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.Based on evaluation of the customer photos, the customer¿s indicated failure mode for molding defect with the incident lot was observed.Additionally, evaluation of the customer samples was conducted and molding defect was observed.Based on the investigation, the most likely root cause for the reported defect is associated with the gate of the molding tool and was determined to be related to a manufacturing issue.As a result, bd is reviewing specific areas in the manufacturing process where the cause of this issue may have originated.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® SST¿ II ADVANCE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7235061
• MDR Text Key: 241266226
• Report Number: 9617032-2018-00003
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K921806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 366566
• Device Lot Number: 7128875
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other