MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER SAFETY-LOK BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367284

Device Problems Backflow (1064); Decrease in Suction (1146)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as nipro is an oem manufacturing site.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced air bubbles forming in the tubing, and back flow of blood from the device to the patient.The following information was provided by the initial reporter.The customer stated: on (b)(6) 2021, in the specialized post-acute care and rehabilitation department, during a blood sampling, the air from the tube goes back up in the epicranial needle tubing with risk of gas embolism.This is a repetitive incident observed on several occasions on several sites before suspecting the tubes.This is a repetitive incident.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.However, since the lot number involved was unknown and no samples were returned, manufacturing and inspection records of 536 lots manufactured under item no.367284 from jan.2019 to dec.2020 were reviewed.As a result, there were not abnormalities which could be related to the reported event.Also, release inspection records of the above 536 lots were reviewed and it was confirmed no appearance defects were found and no leakage from each connection parts or tubing were observed during the product leak tests.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced air bubbles forming in the tubing, and back flow of blood from the device to the patient.The following information was provided by the initial reporter.The customer stated: on (b)(6) 2021, in the specialized post-acute care and rehabilitation department, during a blood sampling, the air from the tube goes back up in the epicranial needle tubing with risk of gas embolism.This is a repetitive incident observed on several occasions on several sites before suspecting the tubes.This is a repetitive incident.

• Brand Name: BD VACUTAINER SAFETY-LOK BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12000150
• MDR Text Key: 256231820
• Report Number: 2243072-2021-01674
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367284
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1