MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER CTAD BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367947
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported during use the bd vacutainer® ctad (buffered sodium citrate theophylline adenosine dipyridamole) blood collection tubes experienced overfill.This event occurred 2 times.The following information was provided by the initial reporter: the customer stated the tubes "are filling all the way to the top passing the line required for blood draw.¿.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for evaluation.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 during use the bd vacutainer® ctad (buffered sodium citrate theophylline adenosine dipyridamole) blood collection tubes experienced overfill.This event occurred 2 times.The following information was provided by the initial reporter: the customer stated the tubes "are filling all the way to the top passing the line required for blood draw.¿.

• Brand Name: BD VACUTAINER CTAD BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 10549347
• Report Number: 9617032-2020-00732
• Device Sequence Number: 3074355
• Product Code: JKA
• UDI-Device Identifier: 50382903679473
• UDI-Public: 50382903679473
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K991120
• 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): 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 367947
• Device Catalogue Number: 367947
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/01/2020
• 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