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

Catalog Number 366408

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that prior to use it was discovered that the labels were falling off the tubes with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: (6 of 7), it was reported that the labels are coming off the tubes.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for label lift 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 a capa #1064141.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.

Event Description

It was reported that prior to use it was discovered that the labels were falling off the tubes with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: (6 of 7).It was reported that the labels are coming off the tubes.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8918837
• MDR Text Key: 155225676
• Report Number: 1024879-2019-01492
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/15/2019
• Device Catalogue Number: 366408
• Device Lot Number: 9074915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other