MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN; 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 01/13/2019

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 a bd vacutainer® cpt¿ cell preparation tube with sodium heparin had rbc contamination in the pbmc layer.

Manufacturer Narrative

H.6.Investigation: 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 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation activities have been conducted through a capa and the most likely root cause has been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Root cause description: although no samples or photos were available for evaluation, bd has initiated further investigation through a capa.The capa has identified the most likely root causes and corrective actions are in the process of being implemented.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.H3 other text : see h.10.

Event Description

It was reported that a bd vacutainer® cpt¿ cell preparation tube with sodium heparin had rbc contamination in the pbmc layer.

• Brand Name: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
• Type of Device: LYMPHOCYTE SEPARATION MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8303354
• MDR Text Key: 135001956
• Report Number: 1917413-2019-00169
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 362753
• Device Lot Number: 8059568
• Initial Date Manufacturer Received: 01/13/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 01/13/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other