MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367925
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Overfill (2404)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.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 overfill occurred after use with a bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes.The following information was provided by the initial reporter, "the tube overfilled causing the study to be cancelled.Study was cancelled and pt has not returned for redraw.Customer doesn't feel the tube was over filled.It was the reference lab which rejected the specimen because too much plasma was submitted.They are used to getting plasma submitted from the 3-4 ml tubes not the 6 ml tube.Plasma was submitted for lactate testing.Site did not have lot# of tube.Spoke about there being a nominal fill indicator on tube label.Sent label brochure to customer to see the nominal fill line.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
Event or Problem Description
It was reported that overfill occurred after use with a bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes.The following information was provided by the initial reporter, "the tube overfilled causing the study to be cancelled.Study was cancelled and pt has not returned for redraw.Customer doesn't feel the tube was over filled.It was the reference lab which rejected the specimen because too much plasma was submitted.They are used to getting plasma submitted from the 3-4 ml tubes not the 6 ml tube.Plasma was submitted for lactate testing.Site did not have lot# of tube.Spoke about there being a nominal fill indicator on tube label.Sent label brochure to customer to see the nominal fill line.".
Event or Problem Description
It was reported that overfill occurred after use with a bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes.The following information was provided by the initial reporter, "the tube overfilled causing the study to be cancelled.Study was cancelled and pt has not returned for redraw.Customer doesn't feel the tube was over filled.It was the reference lab which rejected the specimen because too much plasma was submitted.They are used to getting plasma submitted from the 3-4 ml tubes not the 6 ml tube.Plasma was submitted for lactate testing.Site did not have lot# of tube.Spoke about there being a nominal fill indicator on tube label.Sent label brochure to customer to see the nominal fill line.".
Additional Manufacturer Narrative
The changes are the following: b.3.Date of event: (b)(6) 2020.G.4.Date received by manufacturer: 2020-03-01.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) 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: 9861401
• Report Number: 1917413-2020-00304
• Device Sequence Number: 14291446
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: 50382903679251
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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 Model Number: 367925
• Device Catalogue Number: 367925
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020; 03/02/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 03/27/2020; 03/31/2020
• 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