MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER 18GA 1.88IN; INTRAVASCULAR CATHETER

Model Number	381147
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	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one bd angiocath iv catheter 18ga 1.88in has been found containing foreign matter before use.The following has been provided by the initial reporter: hair got mixed in the package.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received an 18 gauge angiocath unit from lot 4310403 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 a piece of hair inside the sealed package.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that the piece of foreign matter most likely came from the packaging process.These products were manually filled and it was possible for the foreign matter to be introduced during this process.The manufacturing facility has been notified of this incident and the findings.A training was issued for all personnel involved in the packaging process.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It has been reported that one bd angiocath¿ iv catheter 18ga 1.88in has been found containing foreign matter before use.The following has been provided by the initial reporter: hair got mixed in the package.

• Brand Name: BD ANGIOCATH¿ IV CATHETER 18GA 1.88IN
• 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: 9547079
• Report Number: 9610048-2019-00361
• Device Sequence Number: 14301047
• Product Code: FOZ
• UDI-Device Identifier: 30382903811473
• UDI-Public: 30382903811473
• 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): 03/10/2020

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: 11/30/2019
• Device Model Number: 381147
• Device Catalogue Number: 381147
• Device Lot Number: 4310403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/10/2020
• 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