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

Catalog Number	368380
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that there was erroneous results with a bd vacutainer® trace element serum plus blood collection tubes.Traces of cobalt, chromium, molybdenum, tin and vanadium were found.This occurred on 10 separate occasions after use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: (3 of 3 complaints).There are trace amounts of the following in this lot number: cobalt, chromium, molybdenum, tin and vanadium (concentration present is close to the reference interval upper limit).
Event or Problem Description
It was reported that there was erroneous results with a bd vacutainer® trace element serum plus blood collection tubes.Traces of cobalt, chromium, molybdenum, tin and vanadium were found.This occurred on 10 separate occasions after use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: (3 of 3 complaints) there are trace amounts of the following in this lot number: cobalt, chromium, molybdenum, tin and vanadium (concentration present is close to the reference interval upper limit).
Additional Manufacturer Narrative
H.6.Investigation: bd received photos and expired samples from the customer facility for investigation.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.Bd recommends the use of our bd vacutainer® trace elements tube (ref (b)(4) or (b)(4) for analysis of the following: manganese (mn), lead (pb), iron (fe), copper (cu), chromium (cr), cadmium (cd), arsenic (as), antimony (sb), magnesium (mg), calcium (ca), zinc (zn), selenium (se), mercury (hg).We have not validated any of the bd collection tubes for aluminum testing.A review of specimen handling parameters should be reviewed for this tube type.H3 other text : see h.10.

• 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: 9304726
• Report Number: 1917413-2019-02334
• Device Sequence Number: 11283105
• Product Code: JKA
• UDI-Device Identifier: 50382903683807
• UDI-Public: 50382903683807
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 08/31/2019
• Device Catalogue Number: 368380
• Device Lot Number: 8215763
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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