MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 381433

Device Problem Retraction Problem (1536)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.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 needle retraction failure was experienced with a bd insyte autoguard pnk 20ga x 1.0in.The following information was provided by the initial reporter: we have a problem with the bd insyte autoguard today, after the preo-nurse inserted the needle, she could not retrieve the needle back because the push button that instantly retracts got stuck.We had to remove the shielded iv catheter from the patient and do it again.Prior to trying the iv again with the chance of causing more discomfort to the patient, i told the nurse to try the retrieval button with a different needle without doing the iv.We opened 10 needles and different nurses between me, and 3 others tried unsuccessfully to retrieve the needle.The needle retrieval enhances safety for us, less discomfort for the patient (when the first- stick is a success) and minimize phlebitis.None of those goals were met today.

Manufacturer Narrative

Investigation results: received ten 20gx1.00 in insyte autoguard units from lot #3270877.All units were received in sealed packaging.No damage or defects were noted on the returned samples.As it was reported that the needles were not retracting, a functional test of the ten representative samples was completed.Each unit was removed from its sealed packaging, the barrel was rotated while holding the catheter hub to loosen the catheter tubing from the needle as directed in the ifu, and the safety button pushed.The needle from each unit fully retracted without delay and the reported issue was not observed.The complaint could not be confirmed from a functional test of the unused samples.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the complaint of 'needle retraction failure' was not confirmed.Probable root cause conclusion(s): cannot be determined in the absence of a confirmed defect.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOGUARD PNK 20GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18779512
• MDR Text Key: 337309907
• Report Number: 1710034-2024-00136
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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: 381433
• Device Lot Number: 3270877
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1