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

Catalog Number	367981
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot #4303772.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that bd vacutainer® sst¿ tubes had two tubes with no gel.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SST¿ TUBES
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7096503
• Report Number: 1024879-2017-01230
• Device Sequence Number: 781027
• Product Code: JKA
• UDI-Device Identifier: 00382903679812
• UDI-Public: 00382903679812
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K023075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 10/31/2015
• Device Catalogue Number: 367981
• Device Lot Number: 4303772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2015
• Initial Report FDA Received Date: 12/07/2017
• 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