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

Catalog Number	381137
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
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.E1.Street address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
It was reported that bd angiocath leakage.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024, in the intensive care unit of (b)(6) hospital of (b)(6), the patient was admitted to the hospital for pyrexia, and was given an arterial needle for invasive blood pressure monitoring in accordance with the medical advice, and the nurse gave the patient a good needle for the right brachial artery, and then connected the blood pressure monitor, with no abnormality, and then found that there was a small amount of blood oozing from the root of the needle on (b)(6) and then changed the dressing of the needle after re-disinfection of the oozing part.No blood seepage, (b)(6), the root of the indwelling needle and blood leakage, to the blood seepage site disinfection and replacement of the indwelling needle dressing, an hour later observation found that the root of the blood seepage is obvious, and at the same time oozing liquid, can not continue to use, so remove the indwelling needle after replacing the left hand to the patient to re-retaining the indwelling needle can be used normally, this incident has increased the workload of health care personnel, but also increased the patient arterial unwanted! this incident increased the workload of the medical staff and also increased the unwanted damage to the patient's artery.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381137 and lot number 2087291.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Based on the investigation results, an exact cause could not be determined for the reported event.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD 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: 20567904
• Report Number: 9610048-2024-00166
• Device Sequence Number: 12645316
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: (01)00382903811373(11)220429(17)270331(10)2087291
• 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): 02/13/2025

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: 381137
• Device Lot Number: 2087291
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown