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

Catalog Number	381144
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found on the catheter surface of a bd angiocath¿ iv catheter.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Samples/photos: according to visual analysis of received photos, it was possible to verify the presence of silicone droplets on the catheter.The conclusion of the investigations of this complaint does not require the presence of physical samples, the photos that are attached are sufficient for the determination of the defect, not altering the investigation carried out.Dhr/qn/ncmr review: the final assembly batch: 6055447 produced in (b)(6) 2016 a (b)(6) 2016 in acam #1, used in the claimed final product batch: 6217217 of 18g x 1.16in were tested for presence of "foreign/no-foreign matter" and were not evidenced records of this defect.Confirmed: bd was able to confirm the incident in question.Analysis of the photo made it possible to verify the presence of silicone drops in the catheter.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.Based on the investigations conducted for claims of excess silicone of angiocath, it has been found that the root cause of this on the catheter is caused by the excessive amount of silicone that is dispensed during the siliconization of the catheter tip tipping.(b)(4).

• 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: 7412453
• Report Number: 9610048-2018-00038
• Device Sequence Number: 10780515
• Product Code: FOZ
• UDI-Device Identifier: 30382903811442
• UDI-Public: 30382903811442
• 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: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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: 07/31/2021
• Device Catalogue Number: 381144
• Device Lot Number: 6217217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/01/2018
• 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