MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 363080

Device Problem Overfill (2404)

Patient Problem No Code Available (3191)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: the customer did not provide bd pas with product catalog number or lot number information, when requested.After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It was reported that tubes were over filling with a bd vacutainer® 9nc 0.129m plus blood collection tubes.The following information was provided by the initial reporter: (2 of 2 complaints).Customer called asking for an actual size image of the tubes so that the rns can use these to test against the tube after draw as they are having issues with the tubes overfilling and being rejected.Customer did not want to report as a complaint as he thinks this is a technique issue.Lot numbers are not known.Even date unknown.Pts had to be redrawn, no identifiers available and date unknown.

• Brand Name: BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9845164
• MDR Text Key: 190311386
• Report Number: 1920898-2020-00272
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630801
• UDI-Public: 50382903630801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 363080
• Device Catalogue Number: 363080
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2020
• 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