MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS W/GUARDIVA, PROBE COVER; 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	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refq1071 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "patient's picc was inserted on (b)(6) 2022 but patient was sent to another hospital for a while.Recently, patient's nurse noticed the picc was leaking near the extension leg connection hub.No patient harm.The crack was on the extension leg, underneath the grip where the needless connector is changed.Leak occurred during flushing.Picc was removed from patient.".
Event or Problem Description
It was reported "patient's picc was inserted on (b)(6) 2022 but patient was sent to another hospital for a while.Recently, patient's nurse noticed the picc was leaking near the extension leg connection hub.No patient harm.The crack was on the extension leg, underneath the grip where the needless connector is changed.Leak occurred during flushing.Picc was removed from patient.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.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 4fr s/l powerpicc catheter.Usage residues were observed throughout the sample.A needleless injection cap was attached to the luer adapter.The extension tubing markings were completely worn.A partially circumferential split was observed at the luer/tubing joint.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a spraying leak was observed at the split site.Microscopic inspection of the split revealed granular fracture surfaces.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling was observed in the vicinity of the split.The fracture features and material buckling were consistent with material fatigue failure due to repetitive mechanical stresses such as twisting and kinking.The location of the damage suggested that catheter securement, access and maintenance techniques may have contributed.

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS W/GUARDIVA, PROBE COVER
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14179907
• Report Number: 3006260740-2022-01391
• Device Sequence Number: 17628476
• Product Code: LJS
• UDI-Device Identifier: 00801741154935
• UDI-Public: (01)00801741154935
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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 Model Number: N/A
• Device Catalogue Number: 1174108D3
• Device Lot Number: REFQ1071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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 Sex: Unknown