MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY SL 55CM W/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	10/10/2023
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
It was reported by the customer that they have a picc that has needed replaced, as it is leaking thru pinholes in the catheter line.Patient has picc for daptomycin iv from (b)(6) 2023.Hh rn called on (b)(6) 2023 and told us that the line had flushed, aspirated without issue, then went to flush again and fluid came out of the insertion site.He removed the dressing, observed fluid coming from insertion site when flushing, and called me.This line was removed today (b)(6) 2023 and another picc placed for completion of treatment.Upon removal, line was observed to have a pinhole at the 3-4 cm mark.No harm came to the patient, except he missed 1 dose of iv abx.
Event or Problem Description
It was reported by the customer that they have a picc that has needed replaced, as it is leaking thru pinholes in the catheter line.Patient has picc for daptomycin iv from (b)(6) 2023 to (b)(6) 2023.Hh rn called on (b)(6) 2023 and told us that the line had flushed, aspirated without issue, then went to flush again and fluid came out of the insertion site.He removed the dressing, observed fluid coming from insertion site when flushing, and called me.This line was removed today ((b)(6) 2023) and another picc placed for completion of treatment.Upon removal, line was observed to have a pinhole at the 3-4 cm mark.No harm came to the patient, except he missed 1 dose of iv abx.
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 is confirmed and was determined to be use-related.One 4 fr s/l powerpicc was returned for evaluation.An initial visual observation revealed a longitudinally aligned split at the 1 cm depth marker.A microscopic observation revealed the catheter appeared flat at the split site.The split has a granular fracture surface and sharp fracture edges.The catheter was subsequently cut just distal of the observed longitudinal split to measure the wall thickness of the catheter.The wall thickness measured to be within its drawing specifications.Based on the features observed along the split site, the failure is likely due to compression damage or cyclic kinking along the fracture site.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY SL 55CM W/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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18012165
• Report Number: 3006260740-2023-04859
• Device Sequence Number: 15282502
• Product Code: LJS
• UDI-Device Identifier: 00801741028731
• UDI-Public: (01)00801741028731
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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): 01/17/2024

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000060
• Device Lot Number: REHQ1045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/26/2024
• 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: 87 YR
• Patient Sex: Male