MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 363080

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

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 Description

It was reported when using the bd vacutainer® 9nc 0.129m plus blood collection tubes, the device experienced mold within the tube.The following information was provided by the initial reporter.The customer stated: customer states contamination was seen upon opening the plastic wrap on the flat of tubes.Customer states product contains mold within the tube.

Event Description

It was reported when using the bd vacutainer® 9nc 0.129m plus blood collection tubes, the device experienced mold within the tube.The following information was provided by the initial reporter.The customer stated: customer states contamination was seen upon opening the plastic wrap on the flat of tubes.Customer states product contains mold within the tube.

Manufacturer Narrative

H6: investigation summary: bd received 1 photo from the customer in support of this complaint.A visual examination of the photo was performed and revealed foreign matter on the inside of the tube as there are black particles observed in the tube.Bd was able to confirm the customer¿s indicated failure mode with the photo provided.The exact cause for the customer¿s failure mode could not be determined.The device history records 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 h10.

• Brand Name: BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES
• Type of Device: 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: 15886260
• MDR Text Key: 306842825
• Report Number: 1917413-2022-00750
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903630806
• UDI-Public: 00382903630806
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K013971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 363080
• Device Lot Number: 2166974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1