MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; SEE H.10.

Catalog Number 367338

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set.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 when using the bd vacutainer® push button blood collection set, the device experienced insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: since a few days i have noticed a defect with the bd vacutainer sampling wings lot 2102099 21g the valve is not working: no blood return during sampling.The first few times i had to prick the patients several times and asked my colleague for help before i realized that it was a material defect.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: since a few days i have noticed a defect with the bd vacutainer sampling wings lot 2102099 21g.The valve is not working: no blood return during sampling.The first few times i had to prick the patients several times and asked my colleague for help before i realized that it was a material defect.

Manufacturer Narrative

H.6.Investigation summary: bd did not receive samples or photographs from the customer in support of this complaint.Therefore, 10 retained samples from the bd inventory were functionally tested and the issue of insufficient blood flow was not observed.Bd was unable to confirm the customers' indicated failure mode based on the retained samples' test results.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: since a few days i have noticed a defect with the bd vacutainer sampling wings lot 2102099 21g.The valve is not working: no blood return during sampling.The first few times i had to prick the patients several times and asked my colleague for help before i realized that it was a material defect.

Manufacturer Narrative

H.6.Investigation summary: mat: 367338.Lot: 2102099.Bd did not receive samples or photographs from the customer in support of this complaint.Therefore, 10 retained samples from the bd inventory were functionally tested and the issue of insufficient blood flow was not observed.Bd was unable to confirm the customers' indicated failure mode based on the retained samples' test results.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Manufacturer Narrative

The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-10-17.H.6.Investigation summary: bd received 1 sample for investigation.The sample was evaluated by functional testing and the indicated failure mode for insufficient blood flow with the incident lot was observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing and the issue of insufficient blood flow was not observed.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.This complaint has been confirmed for the indicated failure mode insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: since a few days i have noticed a defect with the bd vacutainer sampling wings lot 2102099 21g the valve is not working: no blood return during sampling.The first few times i had to prick the patients several times and asked my colleague for help before i realized that it was a material defect.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: SEE H.10.
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15430535
• MDR Text Key: 302762651
• Report Number: 9617032-2022-00889
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673384
• UDI-Public: 00382903673384
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030573
• 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,Followup,Followup,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 367338
• Device Lot Number: 2102099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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