MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ CLOT ACTIVATOR TUBES; BLOOD COLLECTION TUBE

Catalog Number 367987

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: 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.Bd had conducted an on-site visit with the customer on (b)(4) 2017 and had reviewed proper pre-analytical processes, clotting times, centrifugation as well as provided educational information on erroneous potassium results.Following the visit, feedback from the customer indicates that they will be providing additional training to their staff.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.

Event Description

It was reported that when using bd vacutainer® sst¿ clot activator tubes the patients¿ blood work showed high potassium results.Some of the patients were sent to the er and when blood was re-drawn the results were within normal limits.There was no report of injury or medical interventions.

• Brand Name: BD VACUTAINER® SST¿ CLOT ACTIVATOR TUBES
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7152679
• MDR Text Key: 96717560
• Report Number: 1024879-2017-01282
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679879
• UDI-Public: 50382903679879
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367987
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other