MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE; LYMPHOCYTE SEPARATION MEDIUM

Catalog Number 362753

Device Problem Break (1069)

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

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that a bd vacutainer® glass cpt molecular diagnostics tube broke right after turning on the centrifuge.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE
• Type of Device: LYMPHOCYTE SEPARATION MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• 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: 8048107
• MDR Text Key: 126580146
• Report Number: 1917413-2018-03719
• Device Sequence Number: 1
• Product Code: JCF
• UDI-Device Identifier: 50382903627535
• UDI-Public: 50382903627535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 362753
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• 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