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

Catalog Number	381134
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: samples/ photos: were received photos of product angiocath 20gx1.16, catalog: 381134, lot: 7027728, and according to visual analysis it was possible to confirm the presence of foreign matter on the catheter.Dhr review: the angiocath assembled lot: 6361825 used in the final product lot: 7027728 of angiocath 20gx1.16 ww were analyzed and no records of "foreign matter" were evidenced.Investigation conclusion: bd was able to confirm/ reproduce the incident in question.After analysis of the photos containing the claimed sample, it was possible to confirm the presence of foreign matter.Root cause description: according to studies and plans to reduce foreign matter complaints made by the (b)(4), it can be determined after analyzing the photos that the most probable source for this type of foreign matter may be present due to the following situation.When the catheter is pointed, they get exposed on shelves that had not all the protections, and because they are in a place of people pass, it was likely that some airborne particles would reach the catheter that has silicone along its surface, as evidenced during internal investigations.A conclusion is not yet available as the investigation is still in progress.
Event or Problem Description
It was reported that the catheter on a bd angiocath¿ iv catheter was discolored to black before use.No injury or medical intervention.
Additional Manufacturer Narrative
Results: our quality engineer visually inspected the returned unit and was able to verify the presence of foreign matter on the catheter.No objective evidence of this incident was found during the device history record and quality notifications analysis for the claimed lot.The most probable source of the foreign matter was airborne particles that would reach the catheter and silicone as they were on shelves in the production process.Bd was able to confirm/ reproduce the incident in question.Investigation comments: after analysis of the photos containing the claimed sample, it was possible to confirm the presence of foreign matter.Samples/ photos: were received (b)(4) unused samples of angiocath 20gx1.(b)(4) product; catalog: 381134; batch: 7027728.A visual analysis was performed on the samples, and the presence of the foreign matter on the catheter was not confirmed in accordance with the attached photo 171211-26550-31-2 originally attached for this complaint.Thus, the complaint previously performed based on the photos will remain unchanged.Samples/ photos: were received photos of product angiocath 20gx1.16, catalog: 381134, lot: 7027728, and according to visual analysis it was possible to confirm the presence of foreign matter on the catheter.Dhr review: the angiocath assembled lot: 6361825 used in the final product lot: 7027728 of angiocath 20gx1.16 ww were analyzed and no records of "foreign matter" were evidenced.Qn/ ncmr review: there are no quality notification (qn) or non-conformity report records of foreign matter for the lots involved in this complaint according to the history of the lot above.Conclusion: according to studies and plans to reduce foreign matter complaints made by the (b)(4) plant, it can be determined after analyzing the photos that the most probable source for this type of foreign matter may be present due to the following situation.When the catheter is pointed, they get exposed on shelves that had not all the protections, and because they are in a place of people pass, it was likely that some airborne particles would reach the catheter that has silicone along its surface, as evidenced during internal investigations.

• 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: 7164227
• Report Number: 9610048-2017-00100
• Device Sequence Number: 1372399
• Product Code: FOZ
• UDI-Device Identifier: 30382903811343
• UDI-Public: 30382903811343
• 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,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 01/31/2022
• Device Catalogue Number: 381134
• Device Lot Number: 7027728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/25/2018
• 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