MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367324

Device Problem Difficult to Insert (1316)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

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 push button blood collection set was being used and the patient felt sharp pain.Blood pressure bottomed out, rapid response had to come in.The following information was provided by the initial reporter: ¿material no: (b)(4); batch no: 8261950.It was reported when the customer pushes the button, the needle is still in the vein, some patients are complaining of sharp pain.It was reported when the customer pushes the button, the needle is still in the vein, some patients are complaining of sharp pain.No additional information on how many patients.Customer is inquiring why.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd tech service support team had reached out to the customer site and learned that the patient had felt pain when the needle retracted.Customer noted that the alcohol had dried on the patient's arm.Customer also noted that the patient's blood pressure dropped and required medical attention, as per their protocol.Upon final evaluation, the patient was described as being in normal condition.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd vacutainer® push button blood collection set was being used and the patient felt sharp pain.Blood pressure bottomed out, rapid response had to come in.The following information was provided by the initial reporter: ¿material no: 367324, batch no: 8261950.It was reported when the customer pushes the button, the needle is still in the vein, some patients are complaining of sharp pain.It was reported when the customer pushes the button, the needle is still in the vein, some patients are complaining of sharp pain.No additional information on how many patients.Customer is inquiring why.".

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8453801
• MDR Text Key: 139959643
• Report Number: 1710034-2019-00334
• Device Sequence Number: 0
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 367324
• Device Lot Number: 8261950
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention