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

Catalog Number	381223
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
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 was defective / damaged / deformed when used in the ct room, the catheter interface end protruded and the defective quantity can be returned as 1 unit, claims need to be claimed, complaint response letter is required, complaint receipt letter is required.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned sample, 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 in pr# (b)(4) to address the possible root cause: i.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.Ii.Retrain all insyte tipper pts on pickers height alignment in tipper procedure.The complaint batch was manufactured before the action implementation.
Event or Problem Description
When used in the ct room, the catheter interface end protruded and the defective quantity can be returned as 1 unit, claims need to be claimed, complaint response letter is required, complaint receipt letter is required.

• Brand Name: BD INSYTE BL 22GA X 1.0IN
• 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: 19615010
• Report Number: 2243072-2024-00753
• Device Sequence Number: 12290365
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/18/2024

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: Health Professional
• Device Catalogue Number: 381223
• Device Lot Number: 3279818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/19/2024
• 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