MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported guidewire in midline was stuck in patient.Patient had to have surgery to remove.No other information was provided.
Event or Problem Description
It was reported guidewire in midline was stuck in patient.Patient had to have surgery to remove.No other information was provided.Additional information received on 19-aug-2023: iv team consulted for rua midline check @1000 due to midline not flushing, midline found to be clotted and had to be removed.Md and primary rn were both at beside and plan discussed was to replace midline for continued antibiotic therapy.Care team was able to decide appropriate medication for help with patient's anxiety during insertion and they were to call back iv team once patient was ready.Primary rn messaged that medication was given @ 1250 and iv team arrived at @1325 for insertion.Patient prepped and positioned for insertion, during insertion midline catheter tip was visualized in center of vein on ultrasound, guidewire deployed with no resistance, once catheter advanced resistance was met.Attempted to remove midline, however guidewire was unable to be removed.Md consulted and patient transferred to ir for guidewire retrieval.Patient was sedated.Guidewire was observed to have threaded in a branch of the primary vessel.Ir was able to remove by threading another guidewire into the vessel to catch the tip of the other guidewire and pulled the device out.Exam: foreign body retrieval with fluoroscopic guidance.Wire retrieval entrapped guidewire related to midline catheter placement.Xr chest 1 view dated 2023-07-17 08:56:44 procedure was explained in detail to the patient's mother, and all questions were answered.Informed written and verbal consent were obtained.Monitored anesthesia care was provided by a pediatric cardiac anesthesia team.Left upper arm and existing midline catheter and delivery system were sterilely prepped and draped.Fluoroscopic evaluation of the catheter revealed that the wire was likely looped into a collateral vessel.Initial attempts at removal of the midline catheter and wire were unsuccessful.Wire and catheter were eventually successfully removed under fluoroscopic guidance with fluoroscopic evaluation at the conclusion demonstrating no definite retained catheter or wire fragments.Hemostasis obtained with manual compression.Sterile dressing placed.There were no immediate complications.Total fluoroscopy time for the procedure was 0.9 minutes.Catheter and wire removed without evidence of retained catheter or wire fragments.Catheter and wire components of the midline catheter delivery system were removed under fluoroscopic guidance.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will evaluate.Results are expected soon.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Based on a review of this information, the following was concluded: the complaint of difficulty removing the guidewire of a powerglide pro is confirmed and was determined to be use related.One 22 ga powerglide pro was returned for evaluation.The guidewire in the returned powerglide pro was observed to have disjointed coils throughout the distal end of the guidewire, and the guidewire was observed to have sharp bends coming out of the distal end of the needle.Based on the sharp bends and disjointed coils observed along the returned guidewire of the powerglide pro, the complaint of difficult device removal is confirmed.Insertion into resistance such as tissue can cause damage to the guidewire thus causing difficulty during removal of the guidewire.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported guidewire in midline was stuck in patient.Patient had to have surgery to remove.No other information was provided.Additional information received on 19-aug-2023: iv team consulted for rua midline check @1000 due to midline not flushing, midline found to be clotted and had to be removed.Md and primary rn were both at beside and plan discussed was to replace midline for continued antibiotic therapy.Care team was able to decide appropriate medication for help with patient's anxiety during insertion and they were to call back iv team once patient was ready.Primary rn messaged that medication was given @ 1250 and iv team arrived at @1325 for insertion.Patient prepped and positioned for insertion, during insertion midline catheter tip was visualized in center of vein on ultrasound, guidewire deployed with no resistance, once catheter advanced resistance was met.Attempted to remove midline, however guidewire was unable to be removed.Md consulted and patient transferred to ir for guidewire retrieval.Patient was sedated.Guidewire was observed to have threaded in a branch of the primary vessel.Ir was able to remove by threading another guidewire into the vessel to catch the tip of the other guidewire and pulled the device out.Exam: foreign body retrieval with fluoroscopic guidance.Wire retrieval entrapped guidewire related to midline catheter placement.Xr chest 1 view dated 2023-07-17 08:56:44 procedure was explained in detail to the patient's mother, and all questions were answered.Informed written and verbal consent were obtained.Monitored anesthesia care was provided by a pediatric cardiac anesthesia team.Left upper arm and existing midline catheter and delivery system were sterilely prepped and draped.Fluoroscopic evaluation of the catheter revealed that the wire was likely looped into a collateral vessel.Initial attempts at removal of the midline catheter and wire were unsuccessful.Wire and catheter were eventually successfully removed under fluoroscopic guidance with fluoroscopic evaluation at the conclusion demonstrating no definite retained catheter or wire fragments.Hemostasis obtained with manual compression.Sterile dressing placed.There were no immediate complications.Total fluoroscopy time for the procedure was 0.9 minutes.Catheter and wire removed without evidence of retained catheter or wire fragments.Catheter and wire components of the midline catheter delivery system were removed under fluoroscopic guidance.

• Brand Name: FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17558352
• Report Number: 3006260740-2023-03562
• Device Sequence Number: 4880341
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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 Model Number: N/A
• Device Catalogue Number: F322088PT
• Device Lot Number: REHQ4140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2023
• Supplement Date Received by Manufacturer: 08/19/2023; 11/16/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/29/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: 5 YR
• Patient Sex: Female