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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Arrhythmia (1721); High Blood Pressure/ Hypertension (1908)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that in a double lumen picc solo 5fr catheter, when handling medication from the other access, the access with continuous noradrenaline undergoes interaction, increasing the patient's blood pressure.It was not possible to remove the catheter for analysis due to its dependence on medication.There was a need to cut out a route and puncture a peripheral vein to continue with intermittent medication while the picc was exclusively for noradrenaline.12/26/2022 additional information: patient impacted due to increased blood pressure; customer maintaining power picc solo n.5 fr- double lumen in left upper limb, infusing noradrenaline at 0.03 mcg/kg/min in an exclusive route; when using the other route, which was salinized, during the administration of bolus dipyrone analgesia, the client presented pressure instability, becoming hypertensive and bradycardic, with a pale lip.It was necessary to puncture avp (peripheral venous access) in right upper limb with catheter 20 for intermittent medications.After the incident, we contacted the representative, and she witnessed the moment of salinization of the catheter (the patient again presented pressure instability).Catheter was not flowing back (blood flow); but no flow resistance.In an attempt to use both catheter routes; diluted noradrenaline was started in bi (infusion pump), in order to reduce the incidence of pressure instability caused by the bolus of nora; but without success.On (b)(6) 2022 - off nora; however, it was not possible to aspirate content, which was inside the catheter.On (b)(6) 2022- when salinizing the catheter routes, the client again presents pressure instability (hypertension and bradycardia), and saline solution at 0.02 mcg/kg/min is installed in bs (bag?) in an attempt to saline the picc catheter.On (b)(6) 2022 - stable patient, referred to the infirmary.12/26 - pervious catheter, without use of vad (vasoactive drug).It presents excellent blood return and no resistance to salinization in both pathways.Client hospitalized in the intensive care unit, with a history of falling over a waterfall with tbi, presenting loss of mobility and sensitivity in the lower limbs and upper limbs.In po (on (b)(6) 2022) arthrodesis of c5-c7 and corpectomy of c6.Patient comorbidity of obesity.Patient is currently stable.Statlock and sterile transparent film dressing used for picc.Catheter still currently implanted in the patient.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of refu3001 showed no other similar product complaint(s) from this lot number.
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 by the customer that in a double lumen picc solo 5fr catheter, when handling medication from the other access, the access with continuous noradrenaline undergoes interaction, increasing the patient's blood pressure.It was not possible to remove the catheter for analysis due to its dependence on medication.There was a need to cut out a route and puncture a peripheral vein to continue with intermittent medication while the picc was exclusively for noradrenaline.12/26/2022 additional information: patient impacted due to increased blood pressure; customer maintaining power picc solo n.5 fr- double lumen in left upper limb, infusing noradrenaline at 0.03 mcg/kg/min in an exclusive route; when using the other route, which was salinized, during the administration of bolus dipyrone analgesia, the client presented pressure instability, becoming hypertensive and bradycardic, with a pale lip.It was necessary to puncture avp (peripheral venous access) in right upper limb with catheter 20 for intermittent medications.After the incident, we contacted the representative, and she witnessed the moment of salinization of the catheter (the patient again presented pressure instability).Catheter was not flowing back (blood flow); but no flow resistance.In an attempt to use both catheter routes; diluted noradrenaline was started in bi (infusion pump), in order to reduce the incidence of pressure instability caused by the bolus of nora; but without success.12/22 - off nora; however, it was not possible to aspirate content, which was inside the catheter.12/23- when salinizing the catheter routes, the client again presents pressure instability (hypertension and bradycardia), and saline solution at 0.02 mcg/kg/min is installed in bs (bag?) in an attempt to saline the picc catheter.12/24 - stable patient, referred to the infirmary.12/26 - pervious catheter, without use of vad (vasoactive drug).It presents excellent blood return and no resistance to salinization in both pathways.Client hospitalized in the intensive care unit, with a history of falling over a waterfall with tbi, presenting loss of mobility and sensitivity in the lower limbs and upper limbs.In po (11/12) arthrodesis of c5-c7 and corpectomy of c6.Patient comorbidity of obesity.Patient is currently stable.Stat lock and sterile transparent film dressing used for picc.Catheter still currently implanted in the patient.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16098660
• Report Number: 3006260740-2022-05981
• Device Sequence Number: 6516531
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 1295118
• Device Lot Number: REFU3001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: 33 YR
• Patient Sex: Male
• Patient Weight: 90 KG