MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Customer reported that the patient with picc catheter implantation, implantation date (b)(6)2023.Family reports leakage since catheter implantation.When visiting, the catheter presents a leak at the edge, refluxing all infused medication.Catheter discarded and replaced.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.The complaint of a hub leak is inconclusive due to poor sample condition.One photo sample of a powerpicc luer hub was provided for evaluation.The luer hub is being held by the clinician and an arrow is drawn pointing to it.The presence of a leak or damage that may contribute to a leak could not be clearly observed from the sample.Based on the information provided, possible contributing factors include damaged component and damaged connector interface.Since the presence of a leak could not be clearly observed from the image, the complaint could not be confirmed and remains inconclusive at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
Customer reported that the patient with picc catheter implantation, implantation date (b)(6) 2023.Family reports leakage since catheter implantation.When visiting, the catheter presents a leak at the edge, refluxing all infused medication.Catheter discarded and replaced.No other information was provided.Additional information received 17 july 2023: leakage occurred between the adapter and the catheter.There was no harm to the healthcare professional, but there was harm to the patient, since the medication was not completely infused.It was necessary to change the catheter.There was no exposure of blood or chemotherapy, since the team of professionals decided to administer the chemotherapy through another access.It was not reported which drug was currently being administered.Catheter replaced by surgery.
Event or Problem Description
Customer reported that the patient with picc catheter implantation, implantation date (b)(6) 2023.Family reports leakage since catheter implantation.When visiting, the catheter presents a leak at the edge, refluxing all infused medication.Catheter discarded and replaced.No other information was provided.Additional information received 17 july 2023: leakage occurred between the adapter and the catheter.There was no harm to the healthcare professional, but there was harm to the patient, since the medication was not completely infused.It was necessary to change the catheter.There was no exposure of blood or chemotherapy, since the team of professionals decided to administer the chemotherapy through another access.It was not reported which drug was currently being administered.Catheter replaced by surgery.
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.

• Brand Name: POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER
• 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: 17140100
• Report Number: 3006260740-2023-02458
• Device Sequence Number: 12255377
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 3175118
• Device Lot Number: REFZ2119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 09/06/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/20/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: Other
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 29 KG