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

Catalog Number	381123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
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.
Event or Problem Description
It was reported that bd angiocath cannula breaks.The following information was provided by the initial reporter, translated from italian to english: he found it difficult to use as they "slide with difficulty and the cannula breaks".He tested on 5 pcs of code 381123 (blue).
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381123 and lot number 1110980.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.Per the information received regarding the sample return, no samples belonging to angiocath material 381123 were returned (samples belonged to related (b)(4) ¿ insyte material 381211).Therefore, a thorough sample analysis could not be completed.Based on the investigation results, an exact cause could not be determined for this incident.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.
Event or Problem Description
(b)(6)2024: could you confirm whether there have been negative consequences for the patient? (serious injuries, medical intervention, need to change treatment)? no, no consequences please provide an event date: (b)(6)2024.Has there been an exposure of health care personnel to blood or body fluids? no.Have any other actions been taken? no.

• 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 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19311330
• Report Number: 9610048-2024-00053
• Device Sequence Number: 3009313
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: (01)00382903811236
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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 Catalogue Number: 381123
• Device Lot Number: 1110980
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown