MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381437
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using the it separated and remained in patients arm requiring surgical removal.The following was received by the initial reporter: describe the event or problem: registered nurse (rn) attempting iv placement in antecubital fossa of right arm.Rn was using ultrasound guidance.Rn was unable to get the catheter into the vein, so began withdrawing the catheter.Upon removal of the catheter, rn noticed that the actual catheter had detached from the needle, and the tip of the plastic catheter remained in the arm.Patient went to surgery the following day to have the retained portion of the catheter removed.Patient was discharged home that same day.
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E.4.Fda notified: the initial reporter also notified the fda via medwatch# (b)(4).
Additional Manufacturer Narrative
H.6.Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.H3 other text : see h10.
Event or Problem Description
It was reported that while using the it separated and remained in patients arm requiring surgical removal.The following was received by the initial reporter: describe the event or problem: registered nurse (rn) attempting iv placement in antecubital fossa of right arm.Rn was using ultrasound guidance.Rn was unable to get the catheter into the vein, so began withdrawing the catheter.Upon removal of the catheter, rn noticed that the actual catheter had detached from the needle, and the tip of the plastic catheter remained in the arm.Patient went to surgery the following day to have the retained portion of the catheter removed.Patient was discharged home that same day.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17674812
• Report Number: 2243072-2023-01561
• Device Sequence Number: 20441696
• Product Code: FOZ
• UDI-Device Identifier: 30382903814375
• UDI-Public: (01)30382903814375
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381437
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/02/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 67 KG