MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381112
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd angiocath catheter defective.The following information was provided by the initial reporter: the customer complained that it was difficult to insert the angiocath to the patient.The user reported that they found difficulty while inserting the angiocath to patient, but they did not find any issue on the device before insertion by visual check.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
To aid in the investigation of this issue, three (3) physical catheter samples were received for evaluation by our quality team.The samples were unused and within sealed packages.Through examination of the samples, no defects or abnormalities were identified.However, based on the examination of the returned affected picture sample, the catheter was observed wrinkled with tip damage, confirming the reported incident.A device history record review was completed for provided material number 381112 and lot number 4298768.The review did identify records of poor catheter tip performance in the related machines, which may have contributed to this reported incident.It is worth noting that adjustments were made related to the catheter tip to improve the catheter quality.These adjustments were performed by operators/preparers in the manufacturing areas.It is most probable that the observed catheter defect resulted during the catheter pointing stage in the tipper machine.According to the corrective maintenance order, adjustments were made to the machinery to mitigate this issue.Actions are being addressed for the issue of catheter tip defect in a corrective and preventive action plan at this time.

• Brand Name: ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22644668
• Report Number: 9610048-2025-00097
• Device Sequence Number: 20984913
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: (01)00382903811120(11)241030(17)290930(10)4298768
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 381112
• Device Lot Number: 4298768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown