MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	368380
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: bd had not received samples or photos from the customer facility for evaluation.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-conformance's during manufacturing of the product.
Event or Problem Description
It was reported that prior to use, foreign matter was discovered in tube with a bd vacutainer® trace element serum plus blood collection tubes.The following information was provided by the initial reporter, translated from (b)(6) to english: fm was found in a tube before use and the concerned tube was thus not used.

• Brand Name: BD VACUTAINER TRACE ELEMENT SERUM PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10164998
• Report Number: 1917413-2020-00512
• Device Sequence Number: 11571596
• Product Code: JKA
• UDI-Device Identifier: 50382903683807
• UDI-Public: 50382903683807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041071
• 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
• Report Date (Section B): 06/10/2020

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2020
• Device Model Number: 368380
• Device Catalogue Number: 368380
• Device Lot Number: 9260633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/17/2020
• 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