MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER W/ SHERLOCK 3CG (TPS) STYLET (4F) (SL); 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	Skin Burning Sensation (4540)
Date of Event	07/14/2023
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that leakage found at the insertion site.Patient complained of burning at the site.Evaluated and found leak at the 2cm mark just below the skin level at the insertion site.Removed.Response received 27 july 2023: the event did not involve an urgent or life-threatening medical situation, cause a clinically significant delay in treatment, interruption in treatment, and caused no harm to the patient.Patient was receiving or planned to receive cefazolin.
Event or Problem Description
It was reported by customer that leakage found at the insertion site.Patient complained of burning at the site.Evaluated and found leak at the 2cm mark just below the skin level at the insertion site.Removed.Response received 27 july 2023: the event did not involve an urgent or life-threatening medical situation, cause a clinically significant delay in treatment, interruption in treatment, and caused no harm to the patient.Patient was receiving or planned to receive cefazolin.
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 leak in the catheter is confirmed but the cause is unknown.One 4fr sl powerpicc catheter was returned for evaluation.During the investigation, a leak was observed in the catheter body from a crescent circumferential split.The findings were consistent with catheter damage caused by contact with a sharp instrument.The fracture edges were sharply formed and had planar (flat) surfaces.The exact cause of the damage is unknown and the short time between the insertion date and the date of discovery suggests this damage may have occurred during insertion.An examination of the catheter structure revealed no potential damage/defect related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h.11.
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that leakage found at the insertion site.Patient complained of burning at the site.Evaluated and found leak at the 2cm mark just below the skin level at the insertion site.Removed.Response received 27 july 2023.The event did not involve an urgent or life-threatening medical situation, cause a clinically significant delay in treatment, interruption in treatment, and caused no harm to the patient.Patient was receiving or planned to receive cefazolin.

• Brand Name: POWERPICC CATHETER W/ SHERLOCK 3CG (TPS) STYLET (4F) (SL)
• 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: 17450402
• Report Number: 3006260740-2023-03330
• Device Sequence Number: 7270265
• Product Code: LJS
• UDI-Device Identifier: 00801741131790
• UDI-Public: (01)00801741131790
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2024

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000677
• Device Lot Number: REHQ1762
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 01/08/2024; 02/01/2024
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/08/2024
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 87 KG