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

Catalog Number	381844
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard catheter 'opens' when trying to advance.The following information was provided by the initial reporter, translated from spanish to english: event description case: patient admitted today to the emergency department with indication for hospitalization due to a diagnosis of gastric tumor and therefore proceeded to cannulate with peripheral venoos catheter number 18 with which the auxiliary nursing staff must perform two punctures due to a defect in the catheter's plastic which makes the puncture more traumatic.2024-iai-3127.Place of operation of the medical device at the time of the event: er.Recurrence: yes.Medical device available for evaluation? no.Attached sample: no photographic evidence is available.Complaint quantity: 1 patient with clinical picture of approximately 2 months of evolution consistent in abdominal pain type colic of moderate intensity, intermittent, after food intake, with partial improvement with buscapine tab 10 mg vo, nausea, asthenia, adynamia, attends appointment in outpatient clinic where they start oral treatment with little clinical improvement, so they request paraclinics finding secondary anemic syndrome, 3 days ago he was evaluated by a rheumatologist in outpatient clinic who requested an evaluation which was performed today at the surgeon's office and reported a cardiac tumor siewert ii, gastric tumor bormann 1, polypoid antrum of 40 mm, for which dr decides to refer him to the emergency department for hospitalization, thoracic and abdominal cat scan, evaluation by nutrition, general surgery, oncology, for which he attends a consultation in the emergency room.Additional information received on 14 jan 2025: in relation to case 553 where it states, ¿procedure to canalize with peripheral venous catheter number 18 with which the nursing assistant must perform two punctions due to defect of the catheter plastic¿.An interview is conducted with the nursing coordination requesting clarity on the defect witnessed, which reports that initially there is difficulty with the opening in the skin that should generate the water (defect manifested in other reports in relation to the bevel) so that when trying to advance the catheter the plastic was opened and traumatized the patient in the advance of the same.
Additional Manufacturer Narrative
E1.Address information was not provided, therefore, xx was used as a place holder.Investigation: a device history record review was completed by our quality engineer team for provided material number 381844 and lot number 4170687.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.A complaint history check was performed, and this is the 3rd related complaint reported with the defect/condition of catheter defective / damaged with lot 4170687 regarding item #381844.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.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE AUTOGUARD
• 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 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: 21277518
• Report Number: 1710034-2025-00099
• Device Sequence Number: 18115854
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440(11)240620(17)270531(10)4170687
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 381844
• Device Lot Number: 4170687
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male