MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER 22GA X 1.00IN; 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	03/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd insyte¿ iv catheter 22ga x 1.00in the end cap was unable to be attached.The following information was provided by the initial reporter, translated from chinese to english: the patient underwent gastroscopy.Before operation, he was prepared to puncture the superficial vein with an indwelling needle.If the puncture was successful, he was given a heparin cap to seal the tube mouth.The heparin cap could not be screwed on.If the heparin cap was replaced, it still could not be screwed on.Make relevant explanations, and conduct superficial vein puncture.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that during use with bd insyte¿ iv catheter 22ga x 1.00in the end cap was unable to be attached.The following information was provided by the initial reporter, translated from chinese to english: the patient underwent gastroscopy.Before operation, he was prepared to puncture the superficial vein with an indwelling needle.If the puncture was successful, he was given a heparin cap to seal the tube mouth.The heparin cap could not be screwed on.If the heparin cap was replaced, it still could not be screwed on.Make relevant explanations, and conduct superficial vein puncture.

• Brand Name: BD INSYTE¿ IV CATHETER 22GA X 1.00IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 30 tuas avenue 2; singapore ; 8015652341
• MDR Report Key: 17348056
• Report Number: 8041187-2023-00351
• Device Sequence Number: 6042117
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 381223
• Device Lot Number: 1111413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male