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

Catalog Number	381112
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd angiocath foreign matter on catheter the following information was provided by the initial reporter, translated from japanese to english: it was reported that when the cap was opened and the tip was checked, there was what appeared to be a foreign object, so it was replaced.
Additional Manufacturer Narrative
E facility name exceeds character limit: (b)(6) medical center.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
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381112 and lot number 3194084.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.To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality team.Through examination of the sample, it appeared that the catheter had "lint" on it.Fourier transform infrared (ftir) spectroscopy was performed to identify the composition of the foreign matter.The ftir results indicated that the foreign matter was probably a silicone polymer; however, the silicone lubricant may have contaminated the foreign material, affecting the test results.The cleaning methods used on the related manufacturing machines were evaluated.On the final assembly line, a ¿paint brush¿ was found that was used to clean the machine to remove cannulas that had fallen inside the machine.The bristles of this paintbrush have characteristics similar to the ¿lint¿ found on the catheter; however, the accuracy of the foreign matter cannot be confirmed from the ftir results.Based on the investigation results, it is most likely that the foreign material resulted from the cleaning of the machine, specifically with the brush used.The paintbrush was removed and actions were implemented to improve the cleaning process of the final assembly machine.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 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19502880
• Report Number: 9610048-2024-00067
• Device Sequence Number: 15446970
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: (01)00382903811120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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 Catalogue Number: 381112
• Device Lot Number: 3194084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown