MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 5F HC 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	10/30/2021
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 refv0067 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc was placed with no tracking/3cg issues.After placement the nurse took the wire out of the picc to examine integrity.When the wire was taken out, the tip of the stylet broke off.Clinician feels as if the integrity of the wire is "off" as it doesn't have the typical bounce that she would normally see.".
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 broken stylet is confirmed; however, the exact cause is unknown.One 3cg stylet and one 5 fr triple lumen powerpicc kit were returned for evaluation.An initial visual observation showed the kit was returned sealed.Use residue was observed on the stylet returned outside of the kit and this stylet was observed to be broken approximately 2.9 cm proximal to its distal tip.The returned kit was opened, and no damage was found on the components within the kit.The 3cg stylet within the kit was found within the catheter and, once the stylet was removed, it was observed to be undamaged.A microscopic observation revealed the breaks in the polyimide tubing of the stylet returned outside the kit were uneven with a rough surface texture and plastic deformation.Some tapering was observed in the polyimide tubing at both break sites.The core wire of the stylet was observed to be protruding from the distal break site and was found to be tapered and angled slightly.No damage was observed on the stylet returned within the sealed kit.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.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "picc was placed with no tracking/3cg issues.After placement the nurse took the wire out of the picc to examine integrity.When the wire was taken out, the tip of the stylet broke off.Clinician feels as if the integrity of the wire is "off" as it doesn't have the typical bounce that she would normally see.".

• Brand Name: POWERPICC CATHETER 5F HC 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12870010
• Report Number: 3006260740-2021-05018
• Device Sequence Number: 14345613
• Product Code: LJS
• UDI-Device Identifier: 00801741188053
• UDI-Public: (01)00801741188053
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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: CK000928
• Device Lot Number: REFV0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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