MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	369714
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experience underfilling tubes when they are about to expire.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that tubes are underfilling and it is "normal" for them to experience underfilling tubes when they are about to expire.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-09-26.H.6.Investigation summary: bd received 1 sample from lot 1350276 and 5 samples from lot 1350273in support of this complaint.The sample tubes were functionally tested and the issue of underfill was not observed.Additionally, 10 retention tubes from the bd inventory were functionally tested and the issue of underfill was not observed.Bd was unable to confirm and/or duplicate the customer¿s indicated failure mode because the defect was not observed in the sample and retention testing.The device history records for both lots were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experience underfilling tubes when they are about to expire.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that tubes are underfilling and it is "normal" for them to experience underfilling tubes when they are about to expire.".
Event or Problem Description
It was reported when using the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes experience underfilling tubes when they are about to expire.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that tubes are underfilling and it is "normal" for them to experience underfilling tubes when they are about to expire.".
Additional Manufacturer Narrative
The following fields have been updated with additional information: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical material #: 363083.D.4.Medical device lot #: 1350273.D.4.Medical device expiration date: 2022-09-30.H.4.Device manufacture date: 2021-12-16.D.4.Medical device lot #: 1350276.D.4.Medical device expiration date: 2022-09-30.H.4.Device manufacture date: 2021-12-16.

• Brand Name: BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15433384
• Report Number: 1917413-2022-00572
• Device Sequence Number: 5594915
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 369714
• Device Catalogue Number: 363083
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 10/10/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/05/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown