MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regw0942 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch that they were unable to pass the picc through the brachial past 11cm.It was difficult to remove the line as though the vessel as vaso spasmed.After waiting approximately 10 seconds, the patient was repositioned, and clinician attempted to pass 11 cm unsuccessfully.Basilic and cephalic veins are too small for the picc on the right arm so the clinician moved to the left side.Sterile field as maintained, and clinician found appropriately sized basilic vein and continued the procedure.Catheter passed easily.Catheter dressed per hospital protocol.Customer reports a small wire fragment was present medial to the proximal shaft of the right humerus.
Event or Problem Description
It was reported via medwatch that they were unable to pass the picc through the brachial past 11cm.It was difficult to remove the line as though the vessel as vaso spasmed.After waiting approximately 10 seconds, the patient was repositioned, and clinician attempted to pass 11 cm unsuccessfully.Basilic and cephalic veins are too small for the picc on the right arm so the clinician moved to the left side.Sterile field as maintained, and clinician found appropriately sized basilic vein and continued the procedure.Catheter passed easily.Catheter dressed per hospital protocol.Customer reports a small wire fragment was present medial to the proximal shaft of the right humerus.
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported via medwatch that they were unable to pass the picc through the brachial past 11cm.It was difficult to remove the line as though the vessel as vaso spasmed.After waiting approximately 10 seconds, the patient was repositioned, and clinician attempted to pass 11 cm unsuccessfully.Basilic and cephalic veins are too small for the picc on the right arm so the clinician moved to the left side.Sterile field as maintained, and clinician found appropriately sized basilic vein and continued the procedure.Catheter passed easily.Catheter dressed per hospital protocol.Customer reports a small wire fragment was present medial to the proximal shaft of the right humerus.
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 complaint of a broken stylet was confirmed.The product returned for evaluation was one 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 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.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16501687
• Report Number: 3006260740-2023-00722
• Device Sequence Number: 3354111
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 9295108D
• Device Lot Number: REGW0942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 06/26/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/19/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Unknown