MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT TOWELETTS

Catalog Number	364954
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).Initial reporter last name: (b)(6).Initial reporter facility: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 16mm x 100mm x 8ml bd vacutainer® plus plastic collection kit towelettes contained foreign matter described as "brownish appearance with dirtiness." no serious injury or medical intervention was reported.
Event or Problem Description
It was reported that 16mm x 100mm x 8ml bd vacutainer plus plastic collection kit toweletts contained foreign matter described as "brownish appearance with dirtiness." no serious injury or medical intervention was reported.
Additional Manufacturer Narrative
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 with the incident lot 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 foreign matter with the incident lot was observed.Based on the investigation, a root cause could not be determined.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: 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT TOWELETTS
• Common Device Name: COLLECTION KIT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7834921
• Report Number: 1917413-2018-03348
• Device Sequence Number: 16756005
• Product Code: JKA
• UDI-Device Identifier: 00382903649464
• UDI-Public: 00382903649464
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 02/28/2019
• Device Catalogue Number: 364954
• Device Lot Number: 7206936
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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