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

Catalog Number	367001
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the bd vacutainer® blood alcohol determinations sodium fluoride has been found experiencing low draw during use.The following has been provided by the initial reporter: material no.367001, batch no.Unknown.It was reported that there are low blood draws.We use the grey stopper, 10ml, vacutainer vials and have had to defend our results in court, with what the defense have called "low" blood draws.The defense claims that the vacuum in the tubes are faulty and that is the reason why an amount less than the 9.3-10.7 ml was collected.(our average collection volume is 7ml for our county).From our experience the cause for a lower blood volume is that the phlebotomist wasn't patient enough and removed the vial before the vacuum was completely used.
Additional Manufacturer Narrative
H.6.Investigation summary: 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.However, bd has initiated further investigation relating to this issue through a capa 260774 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.Bd technical services conducted troubleshooting with the customer and provided educational information on draw volume.Further follow up indicated that the customer had determined that the issue they were experiencing could be attributed to phlebotomist technique.
Event or Problem Description
It has been reported that the bd vacutainer® blood alcohol determinations sodium fluoride has been found experiencing low draw during use.The following has been provided by the initial reporter: material no.367001 batch no.Unknown.It was reported that there are low blood draws.We use the grey stopper, 10ml, vacutainer vials and have had to defend our results in court, with what the defense have called "low" blood draws.The defense claims that the vacuum in the tubes are faulty and that is the reason why an amount less than the 9.3-10.7 ml was collected.(our average collection volume is 7ml for our county).From our experience the cause for a lower blood volume is that the phlebotomist wasn't patient enough and removed the vial before the vacuum was completely used.

• Brand Name: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE
• 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: 9087421
• Report Number: 1917413-2019-02101
• Device Sequence Number: 2184254
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• 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
• Report Date (Section B): 10/08/2019

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: Health Professional
• Device Catalogue Number: 367001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/08/2019
• 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