MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD IV CATHETER ANGIOCATH¿ WITHOUT SAFETY; INTRAVASCULAR CATHETER

Catalog Number	381144
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: 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 of a bd iv catheter angiocath¿ without safety, before use.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Results: our quality engineer was able to verify the presence of droplets of silicone on the catheter.It should be noted that this silicone does not cause damage to the wearer and is used to aid in the slippage of the catheter during venipuncture.The root cause was determined to be excessive amount of silicone that is dispensed during the siliconization of the catheter tip tipper.Confirmed: bd was able to confirm/ reproduce the incident in question.Investigation comments: after analyzing the photo returned from the client, it was possible to confirm the presence of droplets of silicone on the catheter.It should be noted that this silicone does not cause damage to the wearer and is used to aid in the slippage of the catheter during venipuncture.It should be noted that this type of complaint does not require the presence of physical samples, as long as the photos have good resolution and clearly show the defect, as was the case of this complaint would be sufficient to confirm the defect.Samples/ photos: according to visual analysis of the photos received, it was possible to verify the presence of silicone drops 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 lot: 6292139 used in the claimed final product lot: 6350953 of angiocath 18g x 1.16in was tested for presence of "foreign / unfamiliar 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 claim, according to the history of the lot above.Conclusion: 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 tipper.For more details on root cause check capa # (b)(4).

• Brand Name: BD IV CATHETER ANGIOCATH¿ WITHOUT SAFETY
• 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: 7199540
• Report Number: 9610048-2017-00115
• Device Sequence Number: 13746606
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: 11/30/2021
• Device Catalogue Number: 381144
• Device Lot Number: 6350953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 01/26/2018
• 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