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

Model Number	363047
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown device manufacture date: unknown.Investigation summary: no samples or photos were returned by the customer in support of this complaint from catalog 364305, lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.
Event or Problem Description
It was reported when using the bd vacutainer® blood collection tube buffered sodium citrate there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "for several months now, the sampling departments have been reporting difficulties in filling these tubes.These filling problems started at the beginning of the summer (june-july).We have not identified any particular batch of tubes (several batches concerned), however, in the technical data sheet it is specified that the tubes must be stored between 4 and 25°c.".

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE
• 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: 15934402
• Report Number: 1917413-2022-00765
• Device Sequence Number: 17230249
• Product Code: JKA
• UDI-Device Identifier: 50382903630474
• UDI-Public: 50382903630474
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013971
• 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
• Report Date (Section B): 11/22/2022

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: 363047
• Device Catalogue Number: 364305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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