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

Model Number	381112
Medical Device Problem Codes	Contamination (1120); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while attempting to use the bd angiocath¿, burrs were discovered when checking the needle point.The following information was provided by the initial reporter: this is a report about needle point configuration of angiocath.According to the customer's verbatim report, when checking the needle point before venipuncture, the hcp found burrs thereon.
Additional Manufacturer Narrative
Investigation summary: bd received a 20 gauge angiocath device from lot: 8351721 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 droplets of silicone visible on the catheter.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.Based off the visual inspection the engineer was able to verify the reported defect.An investigation has already been opened regarding excess silicone and it was determined to have been caused by excessive silicone being dispensed during the siliconization of the catheter tipping and final assembly process.Corrective actions have already been taken to fix this issue and prevent recurrence.
Additional Manufacturer Narrative
A code updated to material deformation and g code updated to needle as the customer reported a burr on the needle.Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4) on (b)(6) 2025.This documentation is available in bd document management system (sap) as dir (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: angiocath device failure: needle point integrity.
Event or Problem Description
No additional information.

• 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
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15234612
• Report Number: 9610048-2022-00094
• Device Sequence Number: 20058591
• Product Code: FOZ
• UDI-Device Identifier: 30382903811121
• UDI-Public: 30382903811121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 381112
• Device Catalogue Number: 381112
• Device Lot Number: 8351721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown