MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SPECIMEN COLLECTION ASSEMBLY WITH BD¿ BLUNT PLASTIC CANNULA; BLOOD COLLECTION SET

Catalog Number	303380
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that four bd vacutainer® specimen collection assembly(s) with bd¿ blunt plastic cannula had damaged or contaminated packaging, before use.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for foreign matter on the packaging with the incident lot was observed.Additionally, a piece of the packaging appears to have been cut off and sealed into the package.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 foreign matter and issues with the sealing of the product 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® SPECIMEN COLLECTION ASSEMBLY WITH BD¿ BLUNT PLASTIC CANNULA
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7248294
• Report Number: 1024879-2018-00020
• Device Sequence Number: 13672348
• Product Code: FMI
• UDI-Device Identifier: 50382903033800
• UDI-Public: 50382903033800
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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
• Operator of Device: Other
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 303380
• Device Lot Number: 4212851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other