MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® WESTERNGREN SEDIMENTATION RATE DETERMINATION; BLOOD COLLECTION TUBE

Catalog Number	369741
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for tube breakage with the incident lot was observed.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 glass, paper label, 13x75 mm, 2.4 ml bd vacutainer® westerngren sedimentation rate determination, buffered citrate (32.0 mg sodium citrate 4.2 mg citric acid/ml) 0.6 ml, black bd hemogard¿ burst during labeling.No blood exposure to mucous membrane.No injury or medical intervention.
Additional Manufacturer Narrative
A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance during manufacturing of the product.

• Brand Name: BD VACUTAINER® WESTERNGREN SEDIMENTATION RATE DETERMINATION
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7089139
• Report Number: 1917413-2017-00570
• Device Sequence Number: 1873979
• Product Code: JKA
• UDI-Device Identifier: 00382903697410
• UDI-Public: 00382903697410
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: Phlebotomist
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 369741
• Device Lot Number: 6187601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/30/2018
• 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