MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366560
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.(b)(6).Bd received samples from the customer facility for investigation.The samples were not evaluated due to the tubes being expired.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.
Event or Problem Description
It was reported that bd vacutainer® buffered sodium citrate (9nc) blood collection tubes weren¿t filling at the correct volume.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7526785
• Report Number: 2243072-2018-00605
• Device Sequence Number: 10805308
• Product Code: JKA
• UDI-Device Identifier: 50382903665605
• UDI-Public: 50382903665605
• Combination Product (Y/N): N
• PMA/510(K) Number: K013971
• 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): 05/18/2018

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: Other
• Device Catalogue Number: 366560
• Device Lot Number: 7180809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 05/18/2018
• 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