MAUDE Adverse Event Report: BECTON DICKINSON D INSYTE BL 22GA X 1.0IN CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte bl 22ga x 1.0in catheter adapter / connector / hub was defective / deformed / molding issue clinicians have reported a couple of incidents with the 22g bd insyte where the plastic around the blue hub where you would place the iv set is faulty it appears that the plastic has been doubled meaning you can attach anything to the cannula when it has been inserted into the patient.I have attached photos to show you.It appears to be the whole lot 3279818 that is affected.
Event or Problem Description
Clinicians have reported a couple of incidents with the 22g bd insyte where the plastic around the blue hub where you would place the iv set is faulty it appears that the plastic has been doubled meaning you can attach anything to the cannula when it has been inserted into the patient.I have attached photos to show you.It appears to be the whole lot 3279818 that is affected.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned photo, observed damaged adapter outer luer thread.The assembly process was reviewed.It was suspected that this defect was caused at the tipper.The most probable cause was the minor height offset between the picker and the gripper, which caused the gripper to slightly crush the outer luer thread when the part was seated at incorrect height (too high or too low).This most likely caused the damage on the outer luer thread.The following action had been implemented on (b)(6) 2024 in pr# (b)(4) to address the possible root cause: conduct complaint awareness training and communication to all insyte tipper production technicians (pts), and to monitor the occurrence of the adapter damaged outer luer thread defect.Retrain all insyte tipper pts on pickers height alignment in tipper procedure.The complaint batch was manufactured before the action implementation.

• Brand Name: D INSYTE BL 22GA X 1.0IN CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19256526
• Report Number: 2243072-2024-00597
• Device Sequence Number: 2685377
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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
• Operator of Device: Other
• Device Catalogue Number: 381223
• Device Lot Number: 3279818
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown