MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROVPPSOLO 4FDL MBP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "when i pulled out the wire, it was dangling at a 90° angle, and pulled off when cleaning wire.I did not clip the 3cg wire when cutting the picc to correct length, because i pulled the wire almost entirely out prior to trimming the picc.The insertion was smooth and had no complications.".
Additional Manufacturer Narrative
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.This event was originally reported as a cascading event under mdr #3006260740-2022-03112.However, during investigation, evaluation of the returned sample showed the report of broken stylet was unrelated to the report of an inability to obtain ecg readings for picc insertion.The report of a broken stylet is now being submitted under this mdr as a separate event.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 frayed stylet was confirmed.The product returned for evaluation was one 3cg/tls stylet.The returned product sample was evaluated and confirmed to be broken.The following observations were made which were consistent with this failure type: microscopic examination revealed revealed deformation of the stylet tubing at magnet edge(s) microscopic examination revealed localized delamination of the stylet tubing at the damage site(s), indicative of tubing kinking/folding kinking of the surrounding stylet tubing, located at magnet interface(s) this additional stylet kinking resulted in a general curl in a similar direction measurements of the stylet tubing, stylet core wire, and magnet were taken and confirmed to be within specifications.Although the break in the wire could be confirmed, the root cause could not be determined through examination of the returned sample.The observed features were indicative of circumstances which included stylet kinking, likely during the insertion process.It appeared that additional unidentified factors may have also contributed.A lot history review (lhr) of reft3551 showed no other similar product complaint(s) from this lot number.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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: 15844755
• Report Number: 3006260740-2022-05465
• Device Sequence Number: 5982909
• Product Code: LJS
• UDI-Device Identifier: 00801741155208
• UDI-Public: (01)00801741155208
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

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: S1294108D5
• Device Lot Number: REFT3551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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