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

Catalog Number 381033

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd insyte autoguard bc shielded iv catheter 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.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional information.

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
• Type of Device: 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: 18882708
• MDR Text Key: 337664462
• Report Number: 1710034-2024-00172
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: (01)00382903810338
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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: 381033
• Device Lot Number: 3040042
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1