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

Catalog Number 381123

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that white foreign matter was found on the bd angiocath¿ iv catheter.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Received in bd sandy three unused 22 g units without packages on (b)(6) 25018 from catalog number 381123, lot number 7209786.Based on the photos and video returned, bd was able to confirm the presence of a clear particle on the catheter thus confirming the complaint of foreign matter.It is should be highlighted that without ftir analysis it is not possible to determine the possible causes and sources of this type of foreign matter.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter with lot #7209786 regarding item (b)(4).A review of the device history record was completed for sub-assembly# (b)(4) lot 7207671 manufactured from 31-jul-17 to 30-aug-17 in acam03 machine used in claimed lot 7209786.This lot was reviewed regarding the tests of ¿foreign matter¿ on the product and were not evidenced records that could lead to claimed defect.Qn/ncmr review: there are no quality notification (qn) or nonconformity report of "foreign matter" that could lead to this complaint for the claimed lot and sub assembled lot.No objective evidence of this incident was found during the device history record and quality notifications analysis for the claimed lot, therefore, we were unable to determine an exact root cause.Complaints received for this device and the reported defects 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 Description

It was reported that white foreign matter was found on the bd angiocath iv catheter.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Received in bd sandy three unused 22 g units without packages on 10/15/2018 from catalog number 381123, lot number 7209786.Based on the photos and video returned, bd was able to confirm the presence of a clear particle on the catheter thus confirming the complaint of foreign matter.It is should be highlighted that without ftir analysis it is not possible to determine the possible causes and sources of this type of foreign matter.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter with lot #7209786 regarding item #381123.A review of the device history record was completed for sub-assembly# (b)(4) lot 7207671 manufactured from 31-jul-17 to 30-aug-17 in acam03 machine used in claimed lot 7209786.This lot was reviewed regarding the tests of ¿foreign matter¿ on the product and were not evidenced records that could lead to claimed defect.Qn/ncmr review: there are no quality notification (qn) or nonconformity report of "foreign matter" that could lead to this complaint for the claimed lot and sub assembled lot.No objective evidence of this incident was found during the device history record and quality notifications analysis for the claimed lot, therefore, we were unable to determine an exact root cause.Complaints received for this device and the reported defects 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 Description

It was reported that white foreign matter was found on the bd angiocath iv catheter.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 7965689
• MDR Text Key: 123804681
• Report Number: 9610048-2018-00156
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: 00382903811236
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 381123
• Device Lot Number: 7209786
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other