MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE BLOOD RNA TUBE; SEE H.10

Model Number 762165

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Common device name: system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0100516.Medical device expiration date: 2021-11-30.Device manufacture date: 2020-04-09.Medical device lot #: 0266688.Medical device expiration date: 2022-04-30.Device manufacture date: 2020-09-22.(b)(4).Investigation summary: bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for incorrect label content with the incident lot was not observed.Additionally, fifty (50) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to incorrect label content as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the label info is not able to be displayed with a paxgene® blood rna tube.The following information was provided by the initial reporter: when scanning the qr code, there are no brackets in the number displayed (in contrast to other lot#).

• Brand Name: PAXGENE BLOOD RNA TUBE
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11375941
• MDR Text Key: 240340467
• Report Number: 9617032-2021-00186
• Device Sequence Number: 1
• Product Code: NTW
• UDI-Device Identifier: 54053727621653
• UDI-Public: 54053727621653
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082150
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 762165
• Device Catalogue Number: 762165
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• 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