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

Catalog Number	367986
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.
Event or Problem Description
It was reported that the bd vacutainer® pst¿ gel and lithium heparin (lh) blood collection tubes had cloudy serum and plasma.
Additional Manufacturer Narrative
Correction: event or problem description is corrected to it was reported that the bd vacutainer® sst¿ blood collection tubes had cloudy serum and plasma.Medical device brand name is corrected to bd vacutainer® sst¿ blood collection tubes.Unique identifier (udi) # is corrected to (b)(4).Pma / 510(k)# is corrected to bk050036.
Event or Problem Description
It was reported that the bd vacutainer® sst¿ blood collection tubes had cloudy serum and plasma.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7503408
• Report Number: 1917413-2018-02157
• Device Sequence Number: 13816267
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 367986
• Device Lot Number: 6029902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2016
• Supplement Date Received by Manufacturer: 04/13/2016
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 10/02/2019
• 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