MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367986

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

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

Event Date 11/23/2020

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.(b)(4) investigation summary: 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 Description

It was reported the bd vacutainer® sst¿ blood collection tubes experienced under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer experienced under-filling."customer complained of having low sample draws on multiple bd vacutainer® sst gold top tube, its been going on for about six months.".

• Brand Name: BD VACUTAINER SST BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11006491
• MDR Text Key: 221546430
• Report Number: 1024879-2020-00926
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• 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