MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 6F TRIPLE-LUMEN CATHETER W/ MICROEZ MICROINTRODUCER NURSE 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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
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 the patient had a new catheter exchange on a 6fr tl powerpicc on (b)(6) at night.Additional information received 7/13/2023: catheter was replaced due to a leak.The doctor passed the catheter, there was no flow and reflux, an image exam was performed and detected the need for this exchange, dr.Can complement as necessary.The catheter was exchanged in a surgical center by the same doctor who did the previous one.Patient received sedation, and the patient and family were dissatisfied, but no infection, for the time being identified.Dr.Followed the case closely.Treatment continued with the new catheter.
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
Customer reported the patient had a new catheter exchange on a 6fr tl powerpicc on (b)(6) at night.Additional information received 7/13/2023: catheter was replaced due to a leak.The doctor passed the catheter, there was no flow and reflux, an image exam was performed and detected the need for this exchange, dr.Can complement as necessary.The catheter was exchanged in a surgical center by the same doctor who did the previous one.Patient received sedation, and the patient and family were dissatisfied, but no infection, for the time being identified.Dr.Followed the case closely.Treatment continued with the new catheter.
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 leaking catheter was confirmed.The product returned for evaluation was one 6 fr triple lumen powerpicc.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed at the 9 cm depth marker.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear.'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
Customer reported the patient had a new catheter exchange on a 6fr tl powerpicc on (b)(6) at night.Additional information received 7/13/2023: catheter was replaced due to a leak.The doctor passed the catheter, there was no flow and reflux, an image exam was performed and detected the need for this exchange, dr.Can complement as necessary.The catheter was exchanged in a surgical center by the same doctor who did the previous one.Patient received sedation, and the patient and family were dissatisfied, but no infection, for the time being identified.Dr.Followed the case closely.Treatment continued with the new catheter.

• Brand Name: POWERPICC 6F TRIPLE-LUMEN CATHETER W/ MICROEZ MICROINTRODUCER NURSE 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: 17366797
• Report Number: 3006260740-2023-03088
• Device Sequence Number: 12613655
• Product Code: LJS
• UDI-Device Identifier: 00801741028212
• UDI-Public: (01)00801741028212
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 3386105
• Device Lot Number: REGQ4697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/22/2023; 10/10/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/25/2023; 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: Other
• Patient Age: 19 YR
• Patient Sex: Male