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	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 foreign particles were found on a bd angiocath¿ iv catheter before use.No injury or medical intervention.
Additional Manufacturer Narrative
Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for foreign matter found on the surface of the catheter with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: 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.Capa # (b)(4) has been initiated.
Event or Problem Description
It was reported that foreign particles were found on a bd angiocath¿ iv catheter before use.No injury or medical intervention.

• 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: 7035295
• Report Number: 9610048-2017-00066
• Device Sequence Number: 16427284
• Product Code: FOZ
• UDI-Device Identifier: 30382903811442
• UDI-Public: 30382903811442
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K950301
• 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): 12/21/2017

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: 06/30/2019
• Device Catalogue Number: 381144
• Device Lot Number: 4148188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/08/2018
• 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