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

Catalog Number 367921

Device Problem Insufficient Information (3190)

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

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for hemolysis with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for hemolysis was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that there was haemolysis with glucose bd vacutainer¿ plastic blood collection tubes - pst plasma separation tube, more than 50%.No serious injury or medical intervention reported.

Manufacturer Narrative

Correction: describe event or problem: it was reported that there was haemolysis with bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes, more than 50%.No serious injury or medical intervention reported.Medical device brand name: bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes.

Event Description

It was reported that there was haemolysis with bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes, more than 50%.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7098881
• MDR Text Key: 94870732
• Report Number: 1917413-2017-00489
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679218
• UDI-Public: 00382903679218
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 367921
• Device Lot Number: 6124901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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