MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1395108D2
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refn0529 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "while placing a triple lumen picc on (b)(6) 2021 i noticed the line was coiling at roughly 35cm.After inspection of the line and wire i noticed the tip of the wire was bent, when touched it broke off onto the sterile drape.No visible signs of fracture were seen prior to attempted placement.I second kit was opened for placement with no signs of fracture in the wire.".
Event or Problem Description
It was reported "while placing a triple lumen picc on (b)(6) 2021 i noticed the line was coiling at roughly 35cm.After inspection of the line and wire i noticed the tip of the wire was bent, when touched it broke off onto the sterile drape.No visible signs of fracture were seen prior to attempted placement.I second kit was opened for placement with no signs of fracture in the wire.".
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged 3cg stylet was confirmed, but the exact cause could not be determined.One 3cg stylet was returned for investigation.The stylet exhibited evidence of use and had been removed from the picc.There was a break in the tubing 1.9 cm from the distal tip of the stylet.The core wire extended 2.55 cm proximal from the break site which indicated that the polyimide tubing had fractured separately from the core wire.The magnet tip contained multiple kink sites proximal of the break.A microscopic examination revealed that the epoxy tip and magnets were present in the distal segment of tubing.The break in the tubing appeared to coincide with a kink in the tubing.No potential manufacture damage, defect, or deformity was seen on the sample.The polyimide tubing was confirmed to be within manufacture specification.The observed fracture features were indicative of catheter and/or stylet kinking and likely occurred during the insertion process.However, the exact circumstances providing for that type of event were ultimately unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT 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
• MDR Report Key: 11720381
• Report Number: 3006260740-2021-01530
• Device Sequence Number: 4219855
• Product Code: LJS
• UDI-Device Identifier: 00801741154911
• UDI-Public: (01)00801741154911
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: S1395108D2
• Device Catalogue Number: S1395108D2
• Device Lot Number: REFN0529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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
• Patient Age: 29 YR
• Patient Weight: 61