MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD RNA TUBE; RNA PREANALYTICAL SYSTEMS

Catalog Number 762165

Device Problem Leak/Splash (1354)

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

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that tubes were discovered to be cracked with a paxgene® blood rna tube.This occurred on 2 separate occasions after use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: i believe there was a misunderstanding in my request as the tubes were purchased in the us and we send them to (b)(6).Then, blood samples were collected in (b)(6) and sent to (b)(6).Upon arrival, we noticed that many of the tubes were cracked.I contacted bd by phone and was given advice on how to better transport the tubes in order to avoid cracking.Since then, we received a new batch of samples and almost all of the tubes were intact this time, 2 out of 90 were cracked.Would you have any specific written recommendation on the shipping process of paxgene tubes in order to avoid cracking? in my initial email, i was not filing a complaint but asking for freezing and shipping recommendations for paxgene tubes.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.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.

Event Description

It was reported that tubes were discovered to be cracked with a paxgene® blood rna tube.This occurred on 2 separate occasions after use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: i believe there was a misunderstanding in my request as the tubes were purchased in the us and we send them to italy.Then, blood samples were collected in italy and sent to us.Upon arrival, we noticed that many of the tubes were cracked.I contacted bd by phone and was given advice on how to better transport the tubes in order to avoid cracking.Since then, we received a new batch of samples and almost all of the tubes were intact this time, 2 out of 90 were cracked.Would you have any specific written recommendation on the shipping process of paxgene tubes in order to avoid cracking? in my initial email, i was not filing a complaint but asking for freezing and shipping recommendations for paxgene tubes.

• Brand Name: PAXGENE® BLOOD RNA TUBE
• Type of Device: RNA PREANALYTICAL SYSTEMS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 10066078
• MDR Text Key: 191551139
• Report Number: 9617032-2020-00418
• Device Sequence Number: 1
• Product Code: NTW
• Combination Product (y/n): N
• PMA/PMN Number: DEN050003
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 762165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other