MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER 3F RADIOLOGY BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reew4464 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "pt.Admitted with a broken picc line.Pt came to ir for a picc rewire; picc line was cracked in half at lumen site." no patient harm was reported, although patient needed a new line placed over a wire.No other information was provided.
Event or Problem Description
It was reported "pt.Admitted with a broken picc line.Pt came to ir for a picc rewire; picc line was cracked in half at lumen site." no patient harm was reported, although patient needed a new line placed over a wire.No other information was provided.
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 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 damaged catheter was confirmed.The product returned for evaluation was one 3fr s/l powerpicc sv catheter.Usage residues were observed throughout the sample.The sample shared a complete break at the luer/tubing joint.Permanent deformation was observed throughout the extension tubing.Microscopic inspection of the break revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material deformation and discoloration were observed in the vicinity of the break.The break features were consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs when repetitive mechanical stresses such as twisting and kinking gradually cause a crack to form and propagate in a material.The location of the damage and extension tubing deformation suggested that device securement, access and maintenance techniques may have contributed.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC SV CATHETER 3F RADIOLOGY BASIC TRAY (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
• MDR Report Key: 11971191
• Report Number: 3006260740-2021-02243
• Device Sequence Number: 19894263
• Product Code: LJS
• UDI-Device Identifier: 00801741027567
• UDI-Public: (01)00801741027567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 3173355
• Device Lot Number: REEW4464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other