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

Model Number 366703

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/21/2019

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 has been reported that one bd vacutainer® no additive (z) tube has been found with a discolored cap before use.The following has been provided by the initial reporter: it was reported that the top on the collection tube was black.Event description per email states: black top on collection tube.

Event Description

It has been reported that one bd vacutainer® no additive (z) tube has been found with a discolored cap before use.The following has been provided by the initial reporter: it was reported that the top on the collection tube was black.Event description per email states: black top on collection tube.

Manufacturer Narrative

H.6.Investigation: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for incorrect cap color with the incident lot was observed.Additionally, evaluation/testing of the customer samples was performed and incorrect cap color 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.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBE
• 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: 9446468
• MDR Text Key: 178132673
• Report Number: 1917413-2019-02508
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Model Number: 366703
• Device Catalogue Number: 366703
• Device Lot Number: 9136716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other