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

Catalog Number	381134
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
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 that before use a bd angiocath¿ iv catheter was found with foreign matter as ¿the catheter has a fringe close to the tip.¿ there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Investigation results: samples or photos have not received for analysis of the incident in question.Our quality engineer was unable to verify the reported complaint.Dhr review: the assembly lot: 7116857, used in the claimed final product lot: 7116857 produced from 04/29/2017 to 05/31/2017 in acam #4, used in the claimed final product lot: 7117509 of angiocath 20ga x 1.16 was checked as testes of presence as "foreign / no foreign matter" and no records of this defect were found.Qn/ ncmr review: there are no records of quality notification (qn) or non-conformance report (rnc) of foreign matter, for the lot involved in this complaint, according to the history of the lot above.Because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to confirm this complaint as being generated by manufacturing process.Based on the investigation results to date the root cause was not determined.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.

• 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: 7366934
• Report Number: 9610048-2018-00030
• Device Sequence Number: 1144146
• Product Code: FOZ
• UDI-Device Identifier: 30382903811343
• UDI-Public: 30382903811343
• 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
• Report Date (Section B): 04/18/2018

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: 04/30/2022
• Device Catalogue Number: 381134
• Device Lot Number: 7117509
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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