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

Catalog Number 362761

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

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

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

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 gel in the bd vacutainer® glass cpt molecular diagnostics tube didn't separate the blood properly.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s).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 and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.

Event Description

It was reported that the gel in the bd vacutainer® glass cpt molecular diagnostics tube didn't separate the blood properly.There was no report of exposure, 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
• MDR Report Key: 7809753
• MDR Text Key: 118234093
• Report Number: 1917413-2018-03341
• Device Sequence Number: 1
• Product Code: JCF
• UDI-Device Identifier: 50382903627610
• UDI-Public: 50382903627610
• Combination Product (y/n): N
• PMA/PMN Number: K911731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 362761
• Device Lot Number: 7272778
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other