MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E; BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING

Catalog Number 362788

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples and 4 photos were received.Evaluation of the photos confirmed the presence of airbubbles in the gel.The photos show tubes with large air bubbles in the gel barrier.No samples were received; therefore, the investigation was limited.Air bubbles in gel are seen when air pockets are in the gel material or if air is introduced into the lines during the dispense process.There are purges that allow the operators to minimize the amount of air bubbles produced from air in the lines, and inspections that minimize the number of tubes released that have air bubbles caused by the air pockets.If small bubbles are present in gel product when the product is sterilized, these bubbles become larger due to the heat.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.The exact cause of the issue could not be determined.

Event Description

It was reported when using the bd vacutainer® ppt¿ plasma preparation tube k2e , the device experienced air bubbles in gel.This event occurred 216 times.The following information was provided by the initial reporter.The customer stated: received complaints concerning 216 abnormal products, 216 bubbles, clinical concerns about the results.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E
• Type of Device: BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12884109
• MDR Text Key: 281343910
• Report Number: 1917413-2021-01009
• Device Sequence Number: 1
• Product Code: PJE
• UDI-Device Identifier: 00382903627882
• UDI-Public: 00382903627882
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972075
• 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
• Report Date: 11/02/2021

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: 02/28/2022
• Device Catalogue Number: 362788
• Device Lot Number: 1040857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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