MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 18G X 1.16IN (1.3 X 30 MM) ANGIOCATH; INTRAVASCULAR CATHETER

Catalog Number	381144
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the 18g x 1.16in (1.3 x 30 mm) angiocath experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: white powder was on the catheter.
Event or Problem Description
It was reported that the 18g x 1.16in (1.3 x 30 mm) angiocath experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: white powder was on the catheter.
Additional Manufacturer Narrative
H.6.Investigation: bd received an 18 gauge angiocath unit from lot 7173829 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed silicone visible on the unit.Silicone was used during the manufacturing process to aid with venipuncture and threading.It has been confirmed that silicone will not cause harm to the user.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that the excess silicone most likely came from the catheter tipping process and final assembly.Capa#450094 was initiated.H3 other text : see h.10.

• Brand Name: 18G X 1.16IN (1.3 X 30 MM) ANGIOCATH
• 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: 9355500
• Report Number: 9610048-2019-00332
• Device Sequence Number: 595727
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 06/30/2022
• Device Catalogue Number: 381144
• Device Lot Number: 7173829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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