MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367001
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
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 brand name: bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.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 the tubes are clotting during use with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.The following information was provided by the initial reporter: it was reported that tubes are clotting.
Event or Problem Description
It was reported that the tubes are clotting during use with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.The following information was provided by the initial reporter: it was reported that tubes are clotting.
Additional Manufacturer Narrative
H.6.Investigation summary : bd integrated diagnostics systems (ids) had not received any sample and/or photos from the customer facility for evaluation; therefore, the investigation was limited.Adhering to the recommended specimen handling and processing steps will facilitate acceptable specimen quality and overall performance for reliable analytical outcomes.This may have been a mixing issue.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.Bd was unable to confirm the customer¿s indicated failure mode because no samples and/or photos were received.We will continue to monitor for additional complaints and emerging trends.H3 other text : see h.10.

• Brand Name: SEE H.10
• 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: 9865381
• Report Number: 1917413-2020-00308
• Device Sequence Number: 19558348
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/11/2020

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 Expiration Date: 03/31/2019
• Device Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: 7067767
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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