MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364816
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® acd solution b blood collection tubes, the device experienced a broken lid/cap.The following information was provided by the initial reporter.The customer stated: one of the tubes from the shelf pack has the cap damaged.
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® acd solution b blood collection tubes, the device experienced a broken lid/cap.The following information was provided by the initial reporter.The customer stated: one of the tubes from the shelf pack has the cap damaged.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for stopper molding defect was observed.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 has been confirmed for the indicated failure mode stopper molding defect.Bd determined that the root cause of the indicated failure mode was attributed to a precured pellet molded onto the stopper and breaking off during further processing.This defect should have been caught by the line operator and removed.

• Brand Name: BD VACUTAINER® ACD SOLUTION B 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: 14115465
• Report Number: 1917413-2022-00198
• Device Sequence Number: 19569676
• Product Code: JKA
• UDI-Device Identifier: 00382903648160
• UDI-Public: 00382903648160
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: NA
• 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
• Report Date (Section B): 05/25/2022

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: 06/30/2023
• Device Catalogue Number: 364816
• Device Lot Number: 1165570
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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