MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS STYLET (3F) (SINGLE-LUMEN); 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	05/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported vat was called urgently to assess leaking picc.Noted hole in the "pigtail" portion of the picc, close to the hard plastic piece that connects to the needleless connector.Underwent at least 10 additional sticks until new picc was placed between iv access and lab draws.Device was placed 3cm below the knee, and neonatal griplock was used to secure.Patient was being treated for s/p enteroplasty and redo ileocolic anastomosis, and has a history of omphaloceale with jejunal atresia.Infusing: d5 77 ns 77 acetate at 5 cc hr, hep flush (b)(6) 18:57 (last 7 days reviewed) cefepime 40mg q 8 last dose (b)(6) 21:58, vancomycin 160 mg q 6 last dose (b)(6) 18:19, tpa (b)(6) 23:36 by vat.Line flushed but did not have blood return only one dose needed.
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.
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 is confirmed; however, the exact cause is unknown.One 3 fr powerpicc sv catheter and two photos were returned for evaluation.The photo samples corresponded with the returned physical sample.Residues and evidence of use were present through the device.The catheter was trimmed at the 31 cm depth marker.A partial break in the proximal end of the purple hub extension tubing was present.A microscopic observation revealed the fracture surface of the split in the extension tubing of the purple lumen was rough and exhibited cracks/fissures and beach marks.Based on the condition of the returned sample, possible contributing factors include material fatigue caused by repeated kinking of the hub and damage during handling.Since a partial split was observed to be present in the extension tubing, the complaint is confirmed; however, the exact contributing factors remain unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported vat was called urgently to assess leaking picc.Noted hole in the "pigtail" portion of the picc, close to the hard plastic piece that connects to the needleless connector.Underwent at least 10 additional sticks until new picc was placed between iv access and lab draws.Device was placed 3cm below the knee, and neonatal griplock was used to secure.Patient was being treated for s/p enteroplasty and redo ileocolic anastomosis, and has a history of omphaloceale with jejunal atresia.Infusing: d5 77 ns 77 acetate at 5 cc hr, hep flush 5/28 18:57.(last 7 days reviewed) cefepime 40mg q 8 last dose 5/26 21:58, vancomycin 160 mg q 6 last dose 5/26 18:19, tpa 5/26 23:36 by vat.Line flushed but did not have blood return only one dose needed.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS STYLET (3F) (SINGLE-LUMEN)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17312983
• Report Number: 3006260740-2023-02904
• Device Sequence Number: 4057778
• 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): 09/11/2023

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000821
• Device Lot Number: REGW2266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: 6 MO
• Patient Sex: Male
• Patient Weight: 7 KG