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

Catalog Number	381444
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.A second lot number was reported for material # 381444 in this complaint: lot # 3181569 mnf 8 jul 2023 exp 30 jun 2026.
Event or Problem Description
It was reported that bd insyte autoguard needles break during the retraction process.The following information was provided by the initial reporter: my team is reporting that our latest batch of angiocaths seem to be malfunctioning, particularly when it comes to retracting the needle after placement of the cannula.Needles have snapped off at the hub as well.This obviously poses a serious risk of needle stick and body fluid exposure.This has occurred several times.The customer is not sure exactly how many times this has occurred but it started with their newest inventory of insyte pivs.Describe patient/hcp/user impact: none.
Additional Manufacturer Narrative
No photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 381444 and lot number 3181569 and 3178603.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.Based on the available information, an exact cause for this incident could not be identified.
Event or Problem Description
No additional information.

• 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: 18279889
• Report Number: 1710034-2023-01408
• Device Sequence Number: 12239605
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 381444
• Device Lot Number: 3178603
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown