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

Catalog Number	382547
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that bd insyte autog bc needle did not retract.The following information was provided by the initial reporter: our pre-op manager just called, and they are having more issues with the insyte catheters.Patients are having more infiltrated iv, pain at the site and bruising.These issues are occurring after the iv has been placed, we do not have any product saved, or lot# identified.We have also had reports from our imaging and iv therapy departments, similar to what we have been seeing with needles not completely retracting, disengaged without button being pushed, etc.Would like to see a meeting on the schedule sooner rather than later.Because of the patient issues of infiltrating, pain and bruising, we are needing to bring in an alternate product right away.
Additional Manufacturer Narrative
Correction: this is a partial needle retraction failure not a complete needle retraction failure.The customer indicates that some had to be 're-poked'- annex f code updated.Report of 'discomfort' related to a different event report.Annex e code updated.
Event or Problem Description
It was reported that bd insyte autog bc needle only partially retracted.Additional information was provided on16 jan 2025: describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Some patients need to be poked twice due to product failure please confirm any needle breakage occurred and found within patients skin? none.
Additional Manufacturer Narrative
Investigation results: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOG BC
• 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: 21179503
• Report Number: 1710034-2025-00025
• Device Sequence Number: 18300336
• Product Code: FOZ
• UDI-Device Identifier: 00382903825479
• UDI-Public: (01)00382903825479
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2025

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: 382547
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: Not provided; 02/02/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 01/22/2025; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown