MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381134
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 2 angiocath pnk 20ga x 1.16in contained foreign matter.The following information was provided by the initial reporter: "when checking the angiocath before use for a patient, the hcp found that a large amount of a lubricant was applied to the catheter.The customer did not use the product and reported to bd.".
Additional Manufacturer Narrative
H.6.Investigation: bd received a 20 gauge angiocath unit from lot 8270866 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 catheter tubing.Silicone is used in the manufacturing process to aid with threading and needle retraction.It should be noted that silicone has been tested and found to not cause damage to the user.Based off the visual inspection the engineer was able to verify the reported condition of excess silicone.It was determined that the excess silicone came from the catheter application/tipping process.The manufacturing facility has been notified of this incident and the findings.
Event or Problem Description
It was reported that 2 angiocath pnk 20ga x 1.16in contained foreign matter.The following information was provided by the initial reporter: "when checking the angiocath before use for a patient, the hcp found that a large amount of a lubricant was applied to the catheter.The customer did not use the product and reported to bd.".

• Brand Name: ANGIOCATH PNK 20GA X 1.16IN
• 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: 10538642
• Report Number: 9610048-2020-00125
• Device Sequence Number: 14190184
• Product Code: FOZ
• UDI-Device Identifier: 30382903811343
• UDI-Public: 30382903811343
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 381134
• Device Catalogue Number: 381134
• Device Lot Number: 8270866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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