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

Catalog Number 381812

Device Problems Crack (1135); Material Rupture (1546)

Patient Problems Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2023

Event Type  malfunction  

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 autoguard ruptures and cracks the following information was provided by the initial reporter, translated from spanish to english: i am writing to you as a healthcare professional to express my deep concern and disappointment regarding the quality of the intravenous catheters supplied by your company.On several occasions, i have had the need to use the products in intravenous medical procedures, and unfortunately, i have experienced repeated problems with the quality of the catheters.It is alarming to note that such devices are coming out defective, with poor quality materials causing serious complications such as phlebitis and vein damage.The problems i have encountered include [specifically describe problems such as fissures, ruptures, skin irritation, but have also resulted in additional complications and costs associated with additional medical treatments.Patient is punctured to the wards but the venous access was not used, no medication or any type of liquid was passed.Impact on the patient: the patient cannot be punctured.On 4 jan 2024: additional information email: i hereby allow myself to share a safety event reported by the newborn unit service, which is related to a 24g intravenous catheter.The service states that they have shown ruptures, cracks in the catheters and skin irritation.

Manufacturer Narrative

Additional information: update on reported issue received from customer.Added to b5.Investigation results: a device history record review was completed by our quality engineer team for provided material number 381812 and lot number 3129613.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

Additional information from customer: according to the review of the patient's clinical history, it is evident that the catheter inserted in the patient is an epicutaneous catheter, so it does not correspond to the catheter you supply.However, feedback has been given to the service, taking into account that the reported lot corresponds to your catheters.A thousand apologies for the erroneous report made.

• Brand Name: BD INSYTE AUTOGUARD
• 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: 18592902
• MDR Text Key: 334838354
• Report Number: 1710034-2024-00044
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: (01)00382903818129
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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
• Device Operator: Other
• Device Catalogue Number: 381812
• Device Lot Number: 3129613
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/28/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female