MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G)(8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	04/28/2023
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 via medwatch ¿this rn was asked to re-visit a possible picc line for continued electrolyte supplementation and frequent lab draws.Patient declined "i have a heart issue, i don't like the idea of that".Patient educated that picc line does not go into the heart but declined.Discussed the option of a midline.Explained that it is 8cm and would not go past shoulder.Patient agreed.Arm prepped with a minute.Chg scrub, and power midline attempted.Ultrasound used.Blood return noted and advancement.Guidewire without difficulty.Resistance met while advancing catheter.Advancement stopped.Immediately and removal of entire powerglide system.Catheter noted to not be intact.Approximately.Half of the catheter noted in the powerglide system.Torniquet applied and direct pressure.Phlebotomist in room and assisted with pressure.Providers notified.Patient without shortness of breath.No complaints.¿.
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.
Event or Problem Description
It was reported via medwatch ¿this rn was asked to re-visit a possible picc line for continued electrolyte supplementation and frequent lab draws.Patient declined "i have a heart issue, i don't like the idea of that".Patient educated that picc line does not go into the heart but declined.Discussed the option of a midline.Explained that it is 8cm and would not go past shoulder.Patient agreed.Arm prepped with a minute.Chg scrub, and power midline attempted.Ultrasound used.Blood return noted and advancement.Guidewire without difficulty.Resistance met while advancing catheter.Advancement stopped.Immediately and removal of entire powerglide system.Catheter noted to not be intact.Approximately.Half of the catheter noted in the powerglide system.Torniquet applied and direct pressure.Phlebotomist in room and assisted with pressure.Providers notified.Patient without shortness of breath.No complaints.¿ additional information received on 31-may-2023: customer reported the following: patient care was delayed due to patient refusing a central line and his other arm was not an option for access.The event created an urgent medical situation to remove the catheter segment to prevent embolism.Patient had an ultrasound and an x-ray were taken.A blood clot developed in the cephalic vein.Pt had to have additional surgery to remove the retained catheter and clot, which was successful.Iv fluids, antibiotics, and electrolyte replacement were the intended infusion medications.
Event or Problem Description
It was reported via medwatch ¿this rn was asked to re-visit a possible picc line for continued electrolyte supplementation and frequent lab draws.Patient declined "i have a heart issue, i don't like the idea of that".Patient educated that picc line does not go into the heart but declined.Discussed the option of a midline.Explained that it is 8cm and would not go past shoulder.Patient agreed.Arm prepped with a minute.Chg scrub, and power midline attempted.Ultrasound used.Blood return noted and advancement.Guidewire without difficulty.Resistance met while advancing catheter.Advancement stopped.Immediately and removal of entire powerglide system.Catheter noted to not be intact.Approximately.Half of the catheter noted in the powerglide system.Torniquet applied and direct pressure.Phlebotomist in room and assisted with pressure.Providers notified.Patient without shortness of breath.No complaints.¿ additional information received on 31-may-2023: customer reported the following: patient care was delayed due to patient refusing a central line and his other arm was not an option for access.The event created an urgent medical situation to remove the catheter segment to prevent embolism.Patient had an ultrasound and an x-ray were taken.A blood clot developed in the cephalic vein.Pt had to have additional surgery to remove the retained catheter and clot, which was successful.Iv fluids, antibiotics, and electrolyte replacement were the intended infusion medications.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2023-02217 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2023-01909.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G)(8CM)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17053244
• Report Number: 3006260740-2023-02217
• Device Sequence Number: 7039305
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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 Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F120080T
• Device Lot Number: REGW1335
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/17/2023; 09/05/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/25/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 86 KG