MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK000821
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that a 3 fr catheter placed in february sprung a leak at the connection between the hub and the external lumen.The line had to be replaced.Additional information received on 4/12/2023: it was reported that on (b)(6) at 2030 fluid was noted by bedside nurse and confirmed by vat.Catheter was removed.New picc placed (b)(6) 2023.Patient unable to receive cpn for 2 days until new line placed.Catheter was secured with secureacath.No patient harm or symptoms related to the fluid leak.
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
It was reported by the customer that a 3 fr catheter placed in february sprung a leak at the connection between the hub and the external lumen.The line had to be replaced.Additional information received on (b)(6) 2023: it was reported that on (b)(6) at 2030 fluid was noted by bedside nurse and confirmed by vat.Catheter was removed.New picc placed (b)(6) 2023.Patient unable to receive cpn for 2 days until new line placed.Catheter was secured with secureacath.No patient harm or symptoms related to the fluid leak.
Additional Manufacturer Narrative
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 extension tubing is confirmed.One 3 fr s/l powerpicc sv was returned for evaluation.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the tubing.An initial visual observation showed use residues throughout the returned catheter.A microscopic observation revealed a split in the tubing just distal of the purple luer.The split exhibited ¿c¿ shaped impressions leading to the fracture site, and beach marks were observed along the fracture surface.The complaint of a leaking catheter where the tubing meets the hub is confirmed.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 16792383
• Report Number: 3006260740-2023-01499
• Device Sequence Number: 5683186
• Product Code: LJS
• UDI-Device Identifier: 00801741152580
• UDI-Public: (01)00801741152580
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• 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
• Report Date (Section B): 06/14/2023

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: 06/30/2023
• Device Catalogue Number: CK000821
• Device Lot Number: REGN3878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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: 4 MO
• Patient Sex: Male
• Patient Weight: 6 KG