MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381112
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is the result of an investigation finding: a device history record review was completed for provided material number 381112 and lot number 3194084.The review did identify one record related to blocking due to ¿flash¿ identified for a sub-assembly component.It is worth noting that after detection, all of the material up to the last check was discarded.There were no quality notifications or non-conformity reports issued for this final product that could have contributed to the reported incident.To aid in the investigation of this issue, twenty (23) sealed samples were returned for evaluation by our quality team.The returned samples were evaluated and five (5) samples were randomly selected for further microscopic examination.One (1) sample showed foreign matter of a yellow color on the catheter body.The foreign matter had the same visual appearance as the adapter.No damage was observed to the catheter tip or cannula tip that could have contributed to the reported issue.The additional samples did not show any signs of damage to the catheter tip or cannula that could have caused the reported defect.Based on the sample investigation, we were unable to identify a cause for difficulty with insertion; however, we were able to identify an issue of foreign matter.As the foreign matter was adhered to the catheter, the molding process was assessed, and no possible risks of loose foreign matter from the molding area were found.The assembly line was assessed and during evaluation, it was identified that the chimneys of the catheter placement station were dirty.It is possible that the observed defect resulted from the molded adapter component presenting some type of micro-burr and during placement of the catheter in the cannula station, the friction of the product with the catheter placement may have released microparticles and in the long term accumulate within the station chimney.As an immediate action, the assembly line machines were cleaned and an improvement action was opened for the cleaning process of the final assembly machine, to include the cleaning of the chimneys at the affected station.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
It was reported by the investigation team that bd angiocath has foreign matter (component fragments/plastic).The following information was provided by the initial reporter, translated from japanese to english: this is a complaint about catheter doesn't slide well.According to the customer report angiocath has become less slippery recently.The customer felt that the product could not be inserted as smoothly as previously.They would like to know if there have been any changes to the material.See h narrative for investigation findings.

• Brand Name: BD ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20788970
• Report Number: 9610048-2024-00189
• Device Sequence Number: 7895204
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: (01)00382903811120(11)230830(17)280731(10)3194084
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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 Catalogue Number: 381112
• Device Lot Number: 3194084
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown