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

Catalog Number	381144
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
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 with the use of the bd angiocath¿ iv catheter there was an issue with foreign matter inside the sealed device package.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018.Previously filed emdr's did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
Event or Problem Description
It was reported with the use of the bd angiocath iv catheter there was an issue with foreign matter inside the sealed device package.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: our quality engineer was able to verify the reported complaint of foreign matter on the device from the sample received.Fourier-transform infrared spectroscopy was able to verify the foreign matter was composed of cellulose, lignin, and silicone on the catheter which appears to be a cardboard particle.Dhr review: a review of the device history record was completed for sub-assembly# 008653bjf lot 7045710 manufactured from 20-feb-17 to 24-feb-17 in acam01 machine used in claimed lot 7173829.This lot was reviewed regarding the tests of ¿foreign matter¿ and no records were found that could lead to the claimed defect.It was not possible to determine the root cause or the source of this type of material, since the use of cardboard inside the production areas is not allowed, the final assembly machine is enclosed and the product remains with the needle cover from final assembly to the product packaging.Thus, it was not possible to determine how a particle of this nature reached the catheter even with the presence of the needle cover.Complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.
Event or Problem Description
It was reported with the use of the bd angiocath¿ iv catheter there was an issue with foreign matter inside the sealed device package.There was no report of injury or further medical intervention.

• 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: 7563243
• Report Number: 9610048-2018-00066
• Device Sequence Number: 2687480
• Product Code: FOZ
• UDI-Device Identifier: 30382903811442
• UDI-Public: 30382903811442
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 10/04/2018

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: 06/30/2022
• Device Catalogue Number: 381144
• Device Lot Number: 7173829
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018; 05/22/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 08/10/2018; 10/04/2018
• 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