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

Catalog Number 365905

Device Problem Fungus in Device Environment (2316)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for foreign matter (fm) was observed.The fm resembles a clump of dried silica.Additionally, twenty (20) retention samples from bd inventory were evaluated by visual examination and the issue of fm was observed in eleven (11) samples.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.This complaint has been confirmed for the indicated failure mode of fm.Bd determined that the root cause of the indicated failure mode was attributed to coating buildup on the tube walls, which dried during manufacturing.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

Event Description

It was reported when using the bd vacutainer® serum blood collection tube there was mold like foreign matter.The following information was provided by the initial reporter.The customer stated: "a mold-like foreign matter was found in the tube.".

Manufacturer Narrative

Investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for foreign matter (fm) was observed.The fm resembles a clump of dried silica.Additionally, twenty (20) retention samples from bd inventory were evaluated by visual examination and the issue of fm was observed in eleven (11) samples.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.This complaint has been confirmed for the indicated failure mode of fm.Bd determined that the root cause of the indicated failure mode was attributed to coating buildup on the tube walls, which dried during manufacturing.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

Event Description

It was reported when using the bd vacutainer® serum blood collection tube there was mold like foreign matter.The following information was provided by the initial reporter.The customer stated: "a mold-like foreign matter was found in the tube.".

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13170781
• MDR Text Key: 285748681
• Report Number: 1024879-2021-00900
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 365905
• Device Lot Number: 1081260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1