MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367986

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Peeling (1999)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd vacutainer® sst¿ blood collection tubes labels are peeling off.This was discovered before use.The following information was provided by the initial reporter: material no.367986, batch no.9067880.It was reported that the labels are peeling off the tubes.It has recently been brought to my attention that the bd vacutainer tubes received over the last few months have an issue where the manufacture labels are peeling off the tubes.The peeling of the tube labels is seen at time of receipt prior to removing the cellophane packaging.

Manufacturer Narrative

Investigation: 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 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 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 bd vacutainer® sst¿ blood collection tubes labels are peeling off.This was discovered before use.The following information was provided by the initial reporter: material no.367986, batch no.9067880.It was reported that the labels are peeling off the tubes.It has recently been brought to my attention that the bd vacutainer tubes received over the last few months have an issue where the manufacture labels are peeling off the tubes.The peeling of the tube labels is seen at time of receipt prior to removing the cellophane packaging.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8941026
• MDR Text Key: 155979997
• Report Number: 1024879-2019-01526
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• 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: 367986
• Device Lot Number: 9067880
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other