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

Catalog Number	381147
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd angiocath¿ iv catheter had a dent.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd angiocath¿ iv catheter had a dent.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
H.6.Investigation: bd was able to verify the received sample had an indention on the catheter and silicone droplets on the catheter.The sample was sent for fourier-transform infrared spectroscopy which verified the silicone.It should be noted that this silicone does not cause damage to the user and is used to aid in the slippage of the catheter during venipuncture.The root cause of this issue on the catheter is caused by the excessive amount of silicone that is dispensed during the siliconization of the catheter tip tipping and final assembly process.A corrective action project, capa#450094, has been initiated to investigate the issue.The root cause for the indentation was not determined.Dhr review: a review of the device history record was completed for sub-assembly #004715bjf lot 7270722 manufactured from 18-oct-2017 to 01-nov-2017 in acam01 machine used in claimed lot 7270758.This lot was reviewed regarding the tests of ¿damaged component¿ and ¿foreign matter¿ and were not evidenced records that could lead to the claimed defect.

• 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: 8366549
• Report Number: 9610048-2019-00121
• Device Sequence Number: 1915678
• Product Code: FOZ
• UDI-Device Identifier: 00382903811472
• UDI-Public: 00382903811472
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 09/30/2022
• Device Catalogue Number: 381147
• Device Lot Number: 7270758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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