MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381912

Device Problem Retraction Problem (1536)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd insyte¿ autoguard¿ winged shielded iv catheter there was a needle retraction failure.The following information was provided by the initial reporter.The customer stated: "the hcp pressed the button but the needle was not retracted.".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one un-retracted needle assembly and seven photos.Upon inspection of the received unit and the photos it was identified that the button could not move resulting in a failure for the needle to retract.The reported defect was confirmed.Further inspection revealed that adhesive was present on the outside of the needle well (hub) and on the tab of the button which was preventing retraction from occurring.During manufacturing, adhesive may be incorrectly placed due to adhesive build up or part misalignment.Preventative maintenance and in process sampling are performed at regular intervals to mitigate the risk from this type of defect.A device history record review could not be performed as the lot number is unknown.H3 other text: see h10.

Event Description

It was reported when using the bd insyte¿ autoguard¿ winged shielded iv catheter there was a needle retraction failure.The following information was provided by the initial reporter.The customer stated: "the hcp pressed the button but the needle was not retracted.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12751218
• MDR Text Key: 280106862
• Report Number: 1710034-2021-00944
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201075
• 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: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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