MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381123
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E.Facility name exceeds characters limit: (b)(6) hospital.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd angiocath catheter separated from hub.The following information was provided by the initial reporter, translated from japanese to english: this is a complaint about the catheter came off the angio catheter hub.It was reported that during a-line puncture, when the customer removed it, only the catheter part remained in the patient.(b)(6)2025.It is stated that "it was reported that during a-line puncture, when the customer removed it, only the catheter part remained in the patient." how was the catheter removed from the patient? unknown.If a procedure or surgical intervention was required, please describe.Were diagnostics required? unknown.If yes, please describe.Unknown.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381123 and lot number 4177030.The review did reveal a ¿failure¿ during the catheter/adapter pull test.The records states that the material was rejected, and a quality notification (qn) was opened.Upon reviewing the history of qns and non-conformance reports, no record was found for the mentioned lot.To aid in the investigation of this issue, the affected physical sample was returned for evaluation by our quality team.Through examination of the sample, it was observed that the catheter was detached from the adapter.It was also confirmed that the defect was not caused by a cut, indicating it was likely related to an error that occurred during the manufacturing process.It is probable that this incident is related to the adapter component¿s b diameter being out of specification and improper cooling of the adapter mold¿s ejector plate.For the defect of catheter broke/separated after insertion, a corrective and preventive action plan was implemented in february 2025.The plan includes revisions for clean queue inspections in the process flow when parts with out of specification b diameter are found, clarification for areas where hot and cold water should be used, validation to provide evidence that the current process is capable of producing parts with b diameter within specifications, updates to risk management, and training conducted with personnel involved in all procedures listed.The catheter lot reported for this incident (lot number 4177030) was manufactured prior to the implementation of this action plan.An action has been proposed to open a qn to address the corrective action related to failure in opening a qn identified for lot number 4177030.A statistical analysis of the inspections carried out throughout the process was performed.A quality alert/informative memo was communicated to personnel, emphasizing the importance of correctly following the procedures and registering the qns.Traceability was performed for the assembled catheter lots used in packaging lots.At this time, further action has not been determined necessary.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
No additional information.

• Brand Name: BD ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• 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: 21562518
• Report Number: 9610048-2025-00021
• Device Sequence Number: 17236710
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: (01)00382903811236(11)240806(17)290630(10)4177030
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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 Catalogue Number: 381123
• Device Lot Number: 4177030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown