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

Model Number 366703

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that before use of the bd vacutainer® no additive (z) tubes there was an issue with tube label lifting.40 tubes had this issue.The following information was provided by the initial reporter: a batch of shipment for the bd item 366703 no additive tube 3ml was being observed by the qa inspector of (distributor) during the ifu insertion activity done in their warehouse.

Manufacturer Narrative

H.6.Investigation summary bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for incorrect/missing label with the incident lot 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.Bd has initiated further investigation relating to this issue through capa 1064141.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.H3 other text : see section h.10.

Event Description

It was reported that before use of the bd vacutainer® no additive (z) tubes there was an issue with tube label lifting.(b)(4) tubes had this issue.The following information was provided by the initial reporter: a batch of shipment for the bd item 366703 no additive tube 3ml was being observed by the qa inspector of (distributor) during the ifu insertion activity done in their warehouse.

• 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: 9632586
• MDR Text Key: 195224478
• Report Number: 1917413-2020-00022
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other