MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD INSYTE AUTOGUARD PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 381433

Device Problem Retraction Problem (1536)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard pnk 20ga x 1.0in is not retracting the needle.The following information was provided by the initial reporter: needle not retracting.

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.

Manufacturer Narrative

Investigation results: a device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOGUARD PNK 20GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• 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: 18857649
• MDR Text Key: 337582356
• Report Number: 1710034-2024-00161
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814336
• UDI-Public: (01)00382903814336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: 381433
• Device Lot Number: 3276371
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1