MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE POTASSIUM OXALATE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367001
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date received by manufacturer has been used for this field.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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 bd vacutainer® ctad blood collection tubes had "underfill".
Additional Manufacturer Narrative
Event or problem description is corrected to it was reported that the bd vacutainer® blood alcohol determinations sodium fluoride potassium oxalate had underfilled.No serious injury or medical intervention.Medical device brand name is corrected to bd vacutainer® blood alcohol determinations sodium fluoride potassium oxalate.Unique identifier (udi) # is corrected (b)(4).Pma/510(k) # is corrected to k901449.(b)(4).
Event or Problem Description
It was reported that the bd vacutainer® blood alcohol determinations sodium fluoride potassium oxalate had underfilled.No serious injury or medical intervention.
Additional Manufacturer Narrative
Correction: per comments in bd internal notes 17-dec-2018 plant number/description were corrected.(b)(4).
Event or Problem Description
It was reported that bd vacutainer ctad blood collection tubes had "underfill".

• Brand Name: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE POTASSIUM OXALATE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7506938
• Report Number: 2243072-2018-00830
• Device Sequence Number: 19276332
• Product Code: JKA
• UDI-Device Identifier: 50382903679473
• UDI-Public: 50382903679473
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2018

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 Catalogue Number: 367001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2015
• Supplement Date Received by Manufacturer: 07/23/2015; 07/23/2015
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/04/2018; 12/20/2018
• 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