MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER; INTRAVASCULAR CATHETER

Model Number	381123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd angiocath¿ peripheral venous catheter was found broken.The following information was provided by the initial reporter: iv catheter found broken in box; no other catheters seemed to be impacted.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Per the originally provided feedback, this record was opened for a defective catheter product found within a shelf carton.The sample returned was an individual insyte autoguard product (material (b)(4) and lot 2318743) which differed from the returned shelf carton for angiocath product (material (b)(4) and lot 1110980).Upon the additional feedback provided, the report that the affected insyte autoguard product was found within the angiocath shelf carton, a secondary investigation was performed for the potential issue of mixed product.A device history record review was completed for originally provided material number (b)(4)and lot number 1110980.The review did not reveal any detected abnormalities during the production or packaging processes that could have contributed to the reported defect and all quality tests were found to be within specification.Material (b)(4) and lot 2318743 are not packaged at the same facility which manufactures and packages material (b)(4) and lot 1110980.Angiocath lot 1110980 was manufactured at bd juiz de for a (brazil) in april 2021.Insyte autogaurd lot 2318743 was manufactured at bd sandy (utah, usa) in november 2022.No mixture of product could have occurred at the bd juiz de fora location.It has also been determined that no mixing could have occurred at the bd distribution center as these products do not pass through the same brazilian distribution center to allow this possibility.At this time, no manufacturing or bd related process could be determined for this reported mixed product issue.

• Brand Name: BD ANGIOCATH¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora 81460 ; BR 81460
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17152841
• Report Number: 3003916417-2023-00131
• Device Sequence Number: 3929596
• Product Code: FOZ
• UDI-Device Identifier: 30382903811237
• UDI-Public: (01)30382903811237
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: Other
• Device Expiration Date: 03/31/2026
• Device Model Number: 381123
• Device Catalogue Number: 381123
• Device Lot Number: 1110980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2021
• 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: Unknown