MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 366703

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that during use of the bd vacutainer no additive (z) tubes there was debris found in tubes.There are 9 occurrence.Customer is reporting complaint of 1 fm non-biological found inside of vacutainer 366703; large white debris.Customer found this 1 tube before use while placing label and double checking tube's quality.Additionally, customer has reported finding red debris in 8 tubes same material/lot that were deemed unsuitable/untestable.

Manufacturer Narrative

H.6.Investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for coring with the incident lot was observed.Additionally, evaluation/testing of the customer samples was performed and coring was observed.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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for coring with the incident lot was observed.Additionally, evaluation of the customer samples was conducted and coring was observed.Root cause description: based on the investigation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during use of the bd vacutainer® no additive (z) tubes there was debris found in tubes.There are 9 occurrence.Customer is reporting complaint of 1 fm non-biological found inside of vacutainer 366703; large white debris.Customer found this 1 tube before use while placing label and double checking tube's quality.Additionally, customer has reported finding red debris in 8 tubes same material/lot that were deemed unsuitable/untestable.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8422578
• MDR Text Key: 139600033
• Report Number: 1917413-2019-00999
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 366703
• Device Lot Number: 8249997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other