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 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

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 bd insyte autoguard pnk 20ga x 1.0in had a needle retraction failure.The following information was provided by the initial reporter: i pulled this product due to the catheter not advancing and the needle will not retract.The catheter is stuck and requires force to slide off of the needle, which will then retract as designed.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: our quality engineer inspected the representative samples submitted for evaluation.Bd received 148 sealed 20ga x 1.00in.Insyte autoguard units from lot number 3270877.A sampling of 125 units were selected to be tested.A penetration and drag test was performed on (b)(4) which tests for catheter penetration, cannula penetration, and drag force.All units met specifications.In addition, retraction failure was also reported therefore a sampling of 20 units were tested.The 20 units were visually inspected, tip adhesion broke, and catheter slightly advanced before retracting the cannula.All units retracted successfully.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in your report.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 18889637
• MDR Text Key: 337702097
• Report Number: 1710034-2024-00177
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814336
• UDI-Public: (01)00382903814336
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/13/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 08/13/2024
• Supplement Dates FDA Received: 08/14/2024
• 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