MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367338

Device Problem Retraction Problem (1536)

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

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: bd received 2 photographs from the customer in support of this complaint.An evaluation of the photographs was performed and provided confirms reported defect of needle retraction.Additionally, 5 retention samples from the bd inventory were taken, and the push button was pressed to retract the needle.All needles retracted as expected.Bd was able confirm the customer¿s indicated failure mode based on the photographs provided, however retained samples were satisfactory.No root cause could be established for the reported defect.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 there was a retraction issue - delay.The following information was provided by the initial reporter.The customer stated: "the needle did not retract properly when the button was pressed.The problem did not occur on any other device.".

Event Description

It was reported when using the bd vacutainer® push button blood collection set there was a retraction issue - delay.The following information was provided by the initial reporter.The customer stated: "the needle did not retract properly when the button was pressed.The problem did not occur on any other device.".

Manufacturer Narrative

The following fields have been updated with additional information: d.9 device available for eval? yes.Returned to manufacturer on - 08/02/2022.H.6.Investigation summary: bd received 1 sample and 2 photographs from the customer in support of this complaint.An evaluation of the sample and photos was performed and the issue of retraction failure was observed, additionally, 5 retention samples from the bd inventory were taken, and the push button was pressed to retract the needle.All needles retracted as expected.Bd was able confirm the customer¿s indicated failure mode based on the evaluation of the sample and the photographs provided, however retained samples were satisfactory.No root cause could be established for the reported defect.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.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 15069738
• MDR Text Key: 297987777
• Report Number: 9617032-2022-00670
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673389
• UDI-Public: 50382903673389
• 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
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 367338
• Device Catalogue Number: 367338
• Device Lot Number: 2024957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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