MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 363083

Device Problem Overfill (2404)

Patient Problem No Code Available (3191)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that overfilling occurred during use with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter, "it was reported during a post market surveillance survey phone call that the customer has experienced overfilling with the tubes.Event description per attached email states: during post market surveillance phone survey call, customer reported issue with sodium citrate light blue top tubes over-filling during sample collection.They had to discard several tubes and re-draw patients for a second sample collection.Customer indicated they only use bd vacutainer tubes for their facility and would like a suggestion on how to prevent the overfilling issue.".

Manufacturer Narrative

H.6 investigation summary : bd had not received samples or photos from the customer facility for evaluation.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa # 295453 the investigation is still on-going and improvements will be made as the potential causes of this issue are identified.H3 other text : see h.10.

Event Description

It was reported that overfilling occurred during use with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter, "it was reported during a post market surveillance survey phone call that the customer has experienced overfilling with the tubes.Event description per attached email states: during post market surveillance phone survey call, customer reported issue with sodium citrate light blue top tubes over-filling during sample collection.They had to discard several tubes and re-draw patients for a second sample collection.Customer indicated they only use bd vacutainer tubes for their facility and would like a suggestion on how to prevent the overfilling issue.".

• Brand Name: BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9819201
• MDR Text Key: 185812084
• Report Number: 1917413-2020-00262
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630832
• UDI-Public: 50382903630832
• Combination Product (y/n): N
• PMA/PMN Number: K013971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Model Number: 363083
• Device Catalogue Number: 363083
• Device Lot Number: 9315357
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other