MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE; LYMPHOCYTE SEPARATION MEDIUM

Catalog Number 362761

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Investigation conclusion as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during use of the bd vacutainer® cpt¿ cell preparation tube with sodium citrate the tube was cracked.

• Brand Name: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
• Type of Device: LYMPHOCYTE SEPARATION MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8240461
• MDR Text Key: 132919922
• Report Number: 1917413-2018-04092
• Device Sequence Number: 1
• Product Code: JCF
• UDI-Device Identifier: 50382903627610
• UDI-Public: 50382903627610
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 362761
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other