MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 13X100 MM 5 ML BD VACUTAINER® SST¿ TUBE. RED BD HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number	368013
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: a device and picture were both returned from the customer.The returned customer samples confirmed missing gel from the tubes.Conclusion: the most likely cause is a process interruption during gel dispense.Tubes were placed back on the line without proper inspection.An engineering project is underway to install a vision sensor to detect missing gel.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5202985.
Event or Problem Description
It was reported that many of the 13x100 mm 5 ml bd vacutainer® sst¿ tube.Red bd hemogard¿ closure that were delivered did not have any gel/additive in the tube.

• Brand Name: 13X100 MM 5 ML BD VACUTAINER® SST¿ TUBE. RED BD HEMOGARD¿ CLOSURE
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7002244
• Report Number: 1024879-2017-00839
• Device Sequence Number: 16433239
• Product Code: JKA
• UDI-Device Identifier: 00382903680139
• UDI-Public: 00382903680139
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K023075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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: 07/31/2016
• Device Catalogue Number: 368013
• Device Lot Number: 5202985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2015
• Initial Report FDA Received Date: 11/04/2017
• 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