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

Catalog Number	369741
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for rubber stopper issues with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion - this occurred during the stopper/shield assembly process.The stopper was pushed in crooked.
Event or Problem Description
It was reported that a rubber stopper of the bd vacutainer® glass westergren blood sedimentation rate determination tubes was assembled in the wrong direction.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® GLASS WESTERGREN BLOOD SEDIMENTATION RATE DETERMINATION TUBES
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7119692
• Report Number: 1917413-2017-00603
• Device Sequence Number: 1824465
• Product Code: JKA
• UDI-Device Identifier: 00382903697410
• UDI-Public: 00382903697410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: 01/31/2017
• Device Catalogue Number: 369741
• Device Lot Number: 5175998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2016
• Initial Report FDA Received Date: 12/14/2017
• 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