MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) PAXGENE® BLOOD DNA TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 768165

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

It was reported when using the paxgene® blood dna tube there was a broken lid/cap and sample leakage.The leakage event occurred 2 times.The broken device issue occurred 1 time.The following information was provided by the initial reporter.The customer stated: this is a report about the following two issues.Leakage of the liquid was found in 2 tubes in a carton containing 100 tubes.A cap with a large split down its side was found on a tube in a carton containing 100 tubes.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2020649.D.4.Medical device expiration date: 2023-06-30.H.4.Device manufacture date: 2022-01-20.D.4.Medical device lot #: 2111720.D.4.Medical device expiration date: 2023-09-30.H.4.Device manufacture date: 2022-04-21.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Bd received 2 samples and 7 photos for investigation.The photos were reviewed and the indicated failure modes for split cap and wet unit label were observed.Additionally, the customer samples along with 100 retention samples from bd inventory, were evaluated by visual examination and the issues of split cap and wet unit label was not observed.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.This complaint has been confirmed for the indicated failure mode split cap and wet unit label.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported when using the paxgene® blood dna tube there was a broken lid/cap and sample leakage.The leakage event occurred 2 times.The broken device issue occurred 1 time.The following information was provided by the initial reporter.The customer stated: this is a report about the following two issues.(1) leakage of the liquid was found in 2 tubes in a carton containing 100 tubes.(2) a cap with a large split down its side was found on a tube in a carton containing 100 tubes.

• Brand Name: PAXGENE® BLOOD DNA TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16820003
• MDR Text Key: 314054670
• Report Number: 9617032-2023-00487
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 768165
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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