MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL 3CG; 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	11/10/2021
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 refr2954 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the customer states they have had a fractured stylet.No other information was provided.
Event or Problem Description
It was reported the customer states they have had a fractured stylet.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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a fractured stylet is confirmed; however, the exact cause is unknown.One 3cg stylet was returned for evaluation.An initial visual observation showed use residue on the returned sample.The polyimide tubing of the returned stylet was observed to be broken 4.2 cm proximal to its distal tip; however, the core wire was observed to be intact.Multiple bends were observed in the polyimide section of the returned stylet.The epoxy tip of the stylet was observed present.A microscopic observation revealed the break sites in the polyimide tubing were uneven with a rough surface texture and plastic deformation.Some tearing and delamination was observed in the polyimide tubing at the break sites.The core wire of the stylet at the break site was observed to be intact and unbroken.Multiple kinks were observed in the polyimide tubing between magnet interfaces, including at the break site.While the exact cause of the break in the returned stylet is unknown, possible causes include excessive manipulation of the stylet prior to or during placement and advancement/retraction of the stylet against resistance.

• Brand Name: POWERPICC PROVENA 5F TL 3CG
• 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: 12911103
• Report Number: 3006260740-2021-05093
• Device Sequence Number: 4751394
• Product Code: LJS
• UDI-Device Identifier: 00801741188824
• UDI-Public: (01)00801741188824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: CK000885
• Device Lot Number: REFR2954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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