MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC GLOBAL; PERIPHERAL IV CATHETERS

Catalog Number 381034

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd insyte autog bc global catheter broke.The following information was provided by the initial reporter, translated from spanish to english: day (b)(6) 2024 day 4 (72 hrs.Of installation _ 08:50_ at the time of atb administration, push with sf is performed.Patient reports pain, volume increase is observed.Decides to remove vvp, informing the patient.Slowly start the removal and with the patient, the patient realizes that the teflon is not completely removed.Eu gently palpates the trajectory and insertion site and does not detect anything, nor is teflon observed at the insertion site.Imaging tests are taken confirming the presence of intraluminal foreign body, and surgical intervention for its removal is decided.

Manufacturer Narrative

Investigation results: the complaint of a broken catheter was confirmed from the two photographs that were provided for investigation.The photos showed a 20g insyte autoguard iv catheter with evidence of use.The catheter tubing was shown in two segments.The proximal segment of the catheter remained attached to the catheter adapter and the distal catheter segment was loose.Without the physical sample or better images of the adjoining ends of the catheter, the root cause could not be determined.Potential contributing factors include material fatigue or sharp instrument damage.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOG BC GLOBAL
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19059536
• MDR Text Key: 339593033
• Report Number: 1710034-2024-00300
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 381034
• Device Lot Number: 3228139
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention