MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Vasculitis (2004)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported lot#s 2276076 and 2225150 were not found for the reported catalog # 381223.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd insyte¿ peripheral iv cannulas with bd vialon¿ biomaterial leaked during use cautiously reported as serious injury.This complaint was created to capture the 2nd of 2 related reportable incidents.The following information was provided by the initial reporter.Translated from french: "the different departments reported a venitis, diffusion or leakage problem the day after the catheter was posted 3 different catheters involved.Patient care: catheter diffused over hand, induration, venitis.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
As neither a confirmed material number nor lot number was available for these incidents, we were unable to complete a production history review and unable to identify if any previous reports have been received for the affected lot regarding this type of defect.Without the physical sample, our quality team was not able to complete a thorough analysis.Although pictures were provided, they did not provide imaging of the product in question for analysis to possibly determine a manufacturing related cause.Based on the limited investigation results, an exact cause for the reported incidents could not be determined.Examination of the product or lot involved in this incident may provide clarification for the cause of this reported failure.Complaints received for this product and defect will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16792217
• Report Number: 8041187-2023-00172
• Device Sequence Number: 5679704
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: 00382903812233
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 381223
• Device Lot Number: SEE H10
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown