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

Catalog Number 366703

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 2 bd vacutainer® no additive (z) tubes had dents.

Event Description

It was reported that 2 bd vacutainer® no additive (z) tubes had dents.

Manufacturer Narrative

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 collapsed tubes with the incident lot was observed.Additionally, evaluation of the customer samples was performed and collapsed tubes 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-conformance's during manufacturing of the product.Investigation conclusion: based on evaluation of the customer samples and photos, the indicated failure mode of collapsed tubes with the incident lot was observed.This complaint investigation was conducted under the premise of a previously investigated issue specific for collapsed tubes, where it was determined that the results and conclusions established in the previous investigations pointed to the same indicated failure mode and root causes observed in the current complaint investigation.Additionally, the conclusion drawn from the current complaint investigation did not yield new information regarding the indicated failure mode.Complaint data for this failure mode is monitored and trended on a routine basis.Root cause description: based on the investigation, a root cause could not be determined.This complaint investigation was conducted under the premise of a previously investigated issue specific for collapsed tubes, where it was determined that the results and conclusions established in the previous investigations pointed to the same indicated failure mode and root causes observed in the current complaint investigation.Additionally, the conclusion drawn from the current complaint investigation did not yield new information regarding the indicated failure mode.Complaint data for this failure mode is monitored and trended on a routine basis.Rationale: 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.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER.
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8375628
• MDR Text Key: 137557811
• Report Number: 1917413-2019-00329
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 366703
• Device Lot Number: 8215681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other