MAUDE Adverse Event Report: BD VACUTAINER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367338

Device Problems Crack (1135); Device Slipped (1584)

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

Event Date 02/01/2015

Event Type  malfunction  

Event Description

During use of the bd vacutainer push button blood collection set, the hub cracked and the wings were very slippery.

• Brand Name: VACUTAINER
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BD; 5859 farinon dr. ste. 200; san antonio TX 78249
• MDR Report Key: 5179953
• MDR Text Key: 29311823
• Report Number: 5179953
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 367338
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1