MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381144
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that before use of the bd angiocath¿ iv catheter a black dot was found on the catheter.
Additional Manufacturer Narrative
Investigation: received one unused unit in an opened package.Bd was able to verify the foreign matter reported.Fourier-transform infrared spectroscopy indicated the material was metallic in nature.This material was then prepared for sem/edx analysis which shows that this material is mainly composed of aluminum, the observed carbon, oxygen, and silicon peaks are most likely from the silicone present on the catheter.The aluminum compound found may have joined the silicone forming the foreign matter found and have originated punctually during the assembly process of the angiocath product and may be related to the excess silicone problem originated from the machine.A corrective action project, capa#450094, has been initiated to investigate the issue of excess silicone.A review of the device history record was completed and there are no quality notification (qn) or nonconformity report of anything that could lead to this complaint.
Event or Problem Description
It was reported that before use of the bd angiocath¿ iv catheter a black dot was found on the catheter.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8331667
• Report Number: 9610048-2019-00111
• Device Sequence Number: 11095851
• Product Code: FOZ
• UDI-Device Identifier: 30382903811442
• UDI-Public: 30382903811442
• 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,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 381144
• Device Lot Number: 7117522
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other