MAUDE Adverse Event Report: BECTON DICKINSON UNSP. BD VACUTAINER BLOOD TRANSF. DEVICE HOLDER PRE-ATTACHED MULTI-SAMP LUER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Device Damaged by Another Device (2915)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.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.

Event Description

It was reported the unspecified bd vacutainer® blood transfer device holder with pre-attached multiple sample female luer adapter experienced insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: the emergency department nurses who have been noting ¿sporadic issues¿ with the standalone smartsite connector.Their process is they start a line (iv) and then put the smartsite directly on the catheter hub.They utilize a bd luer lock vacutainer on the ss to draw blood/labs.This is a process that they have had in place for many years.This may or may not be identified as best practice but it is what they do and it has been working through the years just fine up until recently.They sent a sample of the vacutainer that they used home with me along with a box of smart sites.They noted that some are fine and some are not.In the rest of the hospital, they use the smartsite extension sets 20039e and those nurses note difficulty priming the extension sets.A few things to note: it is sporadic and not every product within a box it seems that at times they have an issue and share it with a coworker and then the product seems to work - (think back to the cracking pressure issues we have had with backcheck valves ¿ very similar description of issue).It is causing some nurses to restart iv¿s which is a invasive and painful procedure for patients.This is affecting our sales opportunities and possible loss of >800k of business related to these sku¿s.

Event Description

It was reported the unspecified bd vacutainer® blood transfer device holder with pre-attached multiple sample female luer adapter experienced insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: the emergency department nurses who have been noting ¿sporadic issues¿ with the standalone smartsite connector.Their process is they start a line (iv) and then put the smartsite directly on the catheter hub.They utilize a bd luer lock vacutainer on the ss to draw blood/labs.This is a process that they have had in place for many years.This may or may not be identified as best practice but it is what they do and it has been working through the years just fine up until recently.They sent a sample of the vacutainer that they used home with me along with a box of smart sites.They noted that some are fine and some are not.In the rest of the hospital, they use the smartsite extension sets 20039e and those nurses note difficulty priming the extension sets.A few things to note: - it is sporadic and not every product within a box - it seems that at times they have an issue and share it with a coworker and then the product seems to work - (think back to the cracking pressure issues we have had with backcheck valves ¿ very similar description of issue) - it is causing some nurses to restart iv¿s which is a invasive and painful procedure for patients - this is affecting our sales opportunities and possible loss of >800k of business related to these sku¿s.

Manufacturer Narrative

Bd had not received samples or photos 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.

• Brand Name: UNSP. BD VACUTAINER BLOOD TRANSF. DEVICE HOLDER PRE-ATTACHED MULTI-SAMP LUER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11686537
• MDR Text Key: 246049042
• Report Number: 2243072-2021-01200
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 06/01/2021

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1