MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366664
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced hemolysis.The following information was provided by the initial reporter.The customer stated: it was reported that patients' labs are rejecting.Update: samples are hemolyzed."they have 9pks left but pulled from units as nurses reported patients' labs were rejecting.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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® sst¿ ii advance plus blood collection tubes, the device experienced hemolysis.The following information was provided by the initial reporter.The customer stated: it was reported that patients' labs are rejecting.Update: samples are hemolyzed."they have 9pks left but pulled from units as nurses reported patients' labs were rejecting.".
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced hemolysis.The following information was provided by the initial reporter.The customer stated: it was reported that patients' labs are rejecting.Update: samples are hemolyzed."they have 9pks left but pulled from units as nurses reported patients' labs were rejecting.".
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to hemolysis as all samples met specifications.The 100 retentions were visually inspected with no issues being identified.The customer has informed us that the issue was resolved.They determined that an incorrect tube was used.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode hemolysis.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS 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: 13461695
• Report Number: 1917413-2022-00053
• Device Sequence Number: 5047214
• Product Code: JKA
• UDI-Device Identifier: 00382903666645
• UDI-Public: 00382903666645
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 366664
• Device Lot Number: 1228010
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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