MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381244
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte gn 18ga x 1.16in leaked after the successful puncture of the indwelling needle, there was leakage at the connection between the inner core of the indwelling needle and the tee extension tube, and the replacement of the tee was still leaking, and it was found that there was a quality problem in the inner core joint of the indwelling needle.
Event or Problem Description
After the successful puncture of the indwelling needle, there was leakage at the connection between the inner core of the indwelling needle and the tee extension tube, and the replacement of the tee was still leaking, and it was found that there was a quality problem in the inner core joint of the indwelling needle.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.Leakage: as current controls, there are outgoing and hourly in-process visual inspections in place to check for catheter adapter and tubing damage.There is also a daily outgoing functional test in place to check for catheter leakage.Needle defect ¿ other: as current control, there is an outgoing and hourly in-process visual inspection in place to check for cannula and catheter damage.As no photo/sample was received for further investigation, root cause could not be determined.The complaint will be re-opened and re-investigated when photo/sample is received.

• Brand Name: BD INSYTE GN 18GA X 1.16IN
• 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: 19461737
• Report Number: 2243072-2024-00672
• Device Sequence Number: 6735449
• Product Code: FOZ
• UDI-Device Identifier: 00382903812448
• UDI-Public: (01)00382903812448
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 381244
• Device Lot Number: 3293950
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown