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

Catalog Number	381134
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 label content is incorrect.The following information was provided by the initial reporter: on (b)(6) 2025, at xxxx, during the incoming inspection of material k-12402-003 lot 33p25c0178 qty (b)(4) ea, it was detected material with different from the graphic and the master sample.The sample consisted of (b)(4) units, all of which were defective.If (b)(4) units in this sample are defective, the batch is rejected.It was documented a no conformity due during the incoming inspection at teleflex chihuahua an issue related to ¿incorrect printing¿.
Additional Manufacturer Narrative
Device evaluation a device history record review was completed for provided material number 381134 and lot number 4222780.The review did not reveal any abnormalities detected during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, seven (7) shelf cartons of product were returned for evaluation by our quality team.Through examination of the picture provided by the customer, it was observed that the graphic on the label paper titled ¿material¿ was different from the graphic on the label paper titled ¿masterpiece.¿ for the returned physical samples, all of the unit packaging had the same labeling.It was confirmed that the label version used on the returned samples was activated in december 2023.The reported batch was packaged in august 2024; therefore, the paper label used in the returned product is correct.It is important to note that the product is compliant, and the change occurred only in the unit packaging paper label.If the customer still has in stock the product shown in the image titled ¿masterpiece,¿ and it is within its shelf life, it can be used without any issues.We understand that this is an issue of confusion regarding the current packaging with the older packaging version.The packaging used is correct for the period in which the product was packaged, and no process errors were identified.No issue is noted for this product.At this time, further action has not been determined necessary.Correction: cancel mdr there is no device/packaging failure.There was an intended graphic design change by the manufacturer.
Event or Problem Description
No additional information.

• 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: 22167479
• Report Number: 9610048-2025-00075
• Device Sequence Number: 15798433
• Product Code: FOZ
• UDI-Device Identifier: 00382903811342
• UDI-Public: (01)00382903811342(11)240829(17)290731(10)4222780
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: Other
• Device Catalogue Number: 381134
• Device Lot Number: 4222780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown