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

Model Number 367820

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported the bd vacutainer® serum blood collection tubes experienced the following information was provided by the initial reporter.The customer stated: it is reported customer witnessed condensation inside of sealed tube.Phone call received, - customer would like to know why there is condensation on the inside of these sealed tubes? if this is not acceptable, they will be needing a replacement.Samples are available.Work order notes: 3/29/2021 explained to the customer, that the condensation is spray coated clot activator, and the tubes are acceptable to use.

Event Description

It was reported the bd vacutainer® serum blood collection tubes experienced the following information was provided by the initial reporter.The customer stated: it is reported customer witnessed condensation inside of sealed tube.Phone call received, - customer would like to know why there is condensation on the inside of these sealed tubes? if this is not acceptable, they will be needing a replacement.Samples are available.Work order notes: 3/29/2021 explained to the customer, that the condensation is spray coated clot activator, and the tubes are acceptable to use.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for evaluation of material # 367820, batch # 0158818.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER SERUM 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: 11709082
• MDR Text Key: 250191050
• Report Number: 1024879-2021-00273
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678209
• UDI-Public: 50382903678209
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 367820
• Device Catalogue Number: 367820
• Device Lot Number: 0158818
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1