MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	1295118
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Confusion/ Disorientation (2553); Increased Level of Consciousness (4590)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the picc leaked, as it had a hole in the inverted cone region.It was necessary to remove the catheter from the patient and perform another insertion procedure.06/21/2023: add info received.On the night shift on (b)(6) 2023 at six o'clock in the morning at the shift changeover, the nurse observed the patient very agitated despite receiving sedation in continuous infusion pump.When the nurse was on duty and went to assess the patient, she observed the wet sheets, and the patient was very agitated.When performing the sas (agitation and sedation scale), she observed medication leakage wetting the sheet.The fracture was external in the middle of the dormonid and fentanyl and the noradrenaline was immediately turned off.Patient experienced psychomotor agitation because he was under orotracheal intubation and sedated.Treatment was performed immediately due to the risk of drug extravasation and the lack of delivery of the drug therapy offered, we decided to remove the catheter and perform a new passage.Replacement procedure was performed at the bedside by the infusion therapy team nurse.Tegaderm chg 3m was used to secure the device.The patient has an ulnar fracture with surgical reapproach that inactivates the implantation of a new catheter in the upper right limb, so a new puncture was performed in the same member of the upper left limb adverse event, exposing the critical patient to a new procedure.No other information was provided.
Additional Manufacturer Narrative
H11: 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.
Event or Problem Description
It was reported the picc leaked, as it had a hole in the inverted cone region.It was necessary to remove the catheter from the patient and perform another insertion procedure.06/21/2023: add info received.On the night shift on 06/14/23 at six o'clock in the morning at the shift changeover, the nurse observed the patient very agitated despite receiving sedation in continuous infusion pump.When the nurse was on duty and went to assess the patient, she observed the wet sheets, and the patient was very agitated.When performing the sas (agitation and sedation scale), she observed medication leakage wetting the sheet.The fracture was external in the middle of the dormonid and fentanyl and the noradrenaline was immediately turned off.Patient experienced psychomotor agitation because he was under orotracheal intubation and sedated.Treatment was performed immediately due to the risk of drug extravasation and the lack of delivery of the drug therapy offered, we decided to remove the catheter and perform a new passage.Replacement procedure was performed at the bedside by the infusion therapy team nurse.Tegaderm chg 3m was used to secure the device.The patient has an ulnar fracture with surgical reapproach that inactivates the implantation of a new catheter in the upper right limb, so a new puncture was performed in the same member of the upper left limb adverse event, exposing the critical patient to a new procedure.No other information was provided.
Event or Problem Description
It was reported the picc leaked, as it had a hole in the inverted cone region.It was necessary to remove the catheter from the patient and perform another insertion procedure.06/21/2023: add info received.On the night shift on (b)(6) 2023 at six o'clock in the morning at the shift changeover, the nurse observed the patient very agitated despite receiving sedation in continuous infusion pump.When the nurse was on duty and went to assess the patient, she observed the wet sheets, and the patient was very agitated.When performing the sas (agitation and sedation scale), she observed medication leakage wetting the sheet.The fracture was external in the middle of the dormonid and fentanyl and the noradrenaline was immediately turned off.Patient experienced psychomotor agitation because he was under orotracheal intubation and sedated.Treatment was performed immediately due to the risk of drug extravasation and the lack of delivery of the drug therapy offered, we decided to remove the catheter and perform a new passage.Replacement procedure was performed at the bedside by the infusion therapy team nurse.Tegaderm chg 3m was used to secure the device.The patient has an ulnar fracture with surgical reapproach that inactivates the implantation of a new catheter in the upper right limb, so a new puncture was performed in the same member of the upper left limb adverse event, exposing the critical patient to a new procedure.No other information was provided.
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 a catheter leak is confirmed but the exact cause remains unknown.One 5 fr dl powerpicc solo catheter was returned for evaluation.The catheter was trimmed at the 44 cm depth marker.Use residues was present throughout the catheter.The catheter was flushed with water and a spraying leak was observed emanating from the molded winged hub.Microscopic inspection of the leak location revealed a pinhole puncture on the molded hub.Based on the condition of the returned sample, possible contributing factors include contain with a sharp instrument or needle.Since a leak was observed to be present at the hub region, the complaint is confirmed but the exact cause remains unknown.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17217879
• Report Number: 3006260740-2023-02677
• Device Sequence Number: 6232363
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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: 05/31/2024
• Device Catalogue Number: 1295118
• Device Lot Number: REHN3948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 10/11/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 09/28/2023; 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 100 KG