MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH GN 18GA X 1.88IN; INTRAVASCULAR CATHETER

Catalog Number	381147
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 foreign matter occurred with angiocath gn 18ga x 1.88in.The following information was provided by the initial reporter, "after opening the unit package, it was foreign matter on catheters.The defect were found on many products.".
Event or Problem Description
It was reported that foreign matter occurred with angiocath gn 18ga x 1.88in.The following information was provided by the initial reporter, "after opening the unit package, it was foreign matter on catheters.The defect were found on many products.".
Additional Manufacturer Narrative
The correction is as follows: g.2 manufacturing location: becton dickinson industrias cirurgicas, ltda.H3 other text : see.H.10.
Event or Problem Description
It was reported that foreign matter occurred with angiocath gn 18ga x 1.88in.The following information was provided by the initial reporter, "after openiing the unit package, it was foreign matter on catheters.The defect were found on many products.".
Additional Manufacturer Narrative
Investigation: bd was able to verify the reported complaint.Two samples were sent for fourier-transform infrared spectroscopy testing indicating the material was most likely cellulose.The probable root cause of this foreign matter made up of similar cellulose components may have joined the silicone to foreign material found and have originated punctually during the assembly process of the angiocath product and may be related to the problem of excess silicone originated from the machine.A corrective action project, capa#45094, has been initiated to investigate the excess silicone issue.Dhr was reviewed and theis lott was reviewed regarding the tests of ¿foreign matter ¿ were not evidenced records that could lead to the claimed defect.

• Brand Name: ANGIOCATH GN 18GA X 1.88IN
• 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: 8566963
• Report Number: 9610048-2019-00163
• Device Sequence Number: 11349328
• Product Code: FOZ
• UDI-Device Identifier: 30382903811473
• UDI-Public: 30382903811473
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2019

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: 03/31/2023
• Device Catalogue Number: 381147
• Device Lot Number: 8086878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 04/10/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/09/2019; 06/11/2019
• 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