MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE GN 18GA X 1.88IN; INTRAVASCULAR CATHETER

Catalog Number	381247
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte gn 18ga x 1.88in cap loose the medical examiner presented to the radiology department on 2024/05/10/ 10:44 for a dirty coronary ct for cardiovascular angiography, and while giving a venipuncture, the nurse observed that the post-return orifice plug in the retractor lumen was dislodged, preventing the catheter from being advanced in a timely manner, resulting in the patient's heavy bleeding.
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
The medical examiner presented to the radiology department on (b)(6)2024 10:44 for a dirty coronary ct for cardiovascular angiography, and while giving a venipuncture, the nurse observed that the post-return orifice plug in the retractor lumen was dislodged, preventing the catheter from being advanced in a timely manner, resulting in the patient's heavy bleeding.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.As current control, there is outgoing inspection and hourly in-process inspection in place to check for damaged components.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 1.88IN
• 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: 19698361
• Report Number: 2243072-2024-00784
• Device Sequence Number: 18060825
• Product Code: FOZ
• UDI-Device Identifier: 00382903812479
• UDI-Public: (01)00382903812479
• 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,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: 381247
• Device Lot Number: 3177853
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown