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

Catalog Number	381134
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	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 before use of the bd angiocath¿ iv catheter foreign matter adheres to the tip of the catheter.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: fm on the catheter tip.
Event or Problem Description
It was reported that before use of the bd angiocath¿ iv catheter foreign matter adheres to the tip of the catheter.Foreign complaint the following information was provided by the initial reporter, translated from japanese to english: fm on the catheter tip.
Additional Manufacturer Narrative
H.6.Investigation summary: a review of the device history record revealed no irregularities during the manufacture of the reported lot.Bd was able to verify the reported complaint of foreign matter.The spectral analysis shows the white material is most likely material from the top web of the angiocath blister pack while the clear material is most likely silicone.It should be noted that this silicone does not cause harm to the wearer and is used to aid in the slippage of the catheter during venipuncture.Based on the investigations conducted for complaints of silicone visible of angiocath, it has been found that the root cause of this issue on the catheter is caused by the excessive amount of silicone that is dispensed during the siliconization of the catheter tip tipping and final assembly process, for the white matter found in the catheter, it was not possible to determine the root cause or the origin of this type of material, since in the assembly area there is no circulation of this material.It was not possible to determine how a particle of this nature reached the catheter.There is a corrective action project has been initiated to investigate the silicone issue.Capa 450094.H3 other text : see section h.10.

• 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: 8772147
• Report Number: 9610048-2019-00222
• Device Sequence Number: 2038954
• Product Code: FOZ
• UDI-Device Identifier: 30382903811343
• UDI-Public: 30382903811343
• 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): 07/19/2019

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: 09/30/2022
• Device Catalogue Number: 381134
• Device Lot Number: 7270757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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