MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381033
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using two bd insyte autoguard bc shielded iv catheters the needle would not retract.The following information was provided by the initial reporter, translated from japanese to english: this is a complaint about needle retraction failure.Customer reported that needle does not retract when button is pressed.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: received 5 photos and two units of a 20gx1.00in insyte autoguard bc device from lot 3040042 for the investigation of this complaint.The units on the photo appear to be the returned physical units.A gross visual inspection shows the needles on both units are retracted in the barrels.One catheter was also provided but the needle covers are missing.Per the customer¿s verbatim the needle did not retract when pressing the safety button and therefore sent the units for investigation.The units were investigated by reengaging the needles and the safety button.The safety button activated without difficulty.After examination of the units, the safety button was pressed, and the needle retracted without resistance.The same activity was repeated on both unit with an addition that the returned catheter was placed over the needle.Even then when pressing the safety button, the needles retracted without difficulty.Since the units retracted safely, the defect of needle retraction failure couldn¿t be confirmed on the units.A device history record review found no non-conformances associated with this issue during production of this batch.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.Investigation conclusion(s): the defect of failure to retract was not confirmed.Probable root cause conclusion(s): cannot be determined in the absence of a reported defect.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• 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: 18498432
• Report Number: 1710034-2023-01524
• Device Sequence Number: 12728654
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: (01)00382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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: 01/31/2026
• Device Catalogue Number: 381033
• Device Lot Number: 3040042
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown