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

Catalog Number 362753

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

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

Event Date 11/12/2018

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 that the samples of bd vacutainer® glass cpt molecular diagnostics tubes did not separate.

Event Description

It was reported that the samples of bd vacutainer® glass cpt molecular diagnostics tubes did not separate.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for poor barrier separation with the incident lot was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for poor barrier separation with the incident lot was not observed.Further investigation activities have been conducted through a capa and the most likely root cause has been identified.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Root cause description: although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s).Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue.The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.

• 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
• MDR Report Key: 8124726
• MDR Text Key: 129324493
• Report Number: 1917413-2018-03857
• Device Sequence Number: 1
• Product Code: JCF
• UDI-Device Identifier: 50382903627535
• UDI-Public: 50382903627535
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 362753
• Device Lot Number: 8186650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other