MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD-N WINGED CATHETER; INTRAVASCULAR CATHETER

Model Number 381511

Device Problem Degraded (1153)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an unspecified number of bd insyte autoguard-n winged catheters experienced defective tubing.The following information was provided by the initial reporter: catheter is stuck in the plastic housing of the pivc needle cover, leading to the catheter shearing when attempting to re-set the pivc.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of these batches.

Event Description

It was reported that an unspecified number of bd insyte autoguard-n winged catheters experienced defective tubing.The following information was provided by the initial reporter: catheter is stuck in the plastic housing of the pivc needle cover, leading to the catheter shearing when attempting to re-set the pivc.

• Brand Name: BD INSYTE AUTOGUARD-N WINGED 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15709616
• MDR Text Key: 306814268
• Report Number: 1710034-2022-00642
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815112
• UDI-Public: 30382903815112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

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 Model Number: 381511
• Device Catalogue Number: 381511
• Device Lot Number: 2073751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1