MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the picc was knotted in the axillary crease.It was pulled out fine with no harm to the patient.Once clinician realized it was stuck in axillary crease, they started rubbing the site back and forth.Add info received 01/12/2023 customer reported they pulled out the wire and dilator.No other information was provided.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of regt3315 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that the picc was knotted in the axillary crease.It was pulled out fine with no harm to the patient.Once clinician realized it was stuck in axillary crease, they started rubbing the site back and forth.Add.Info received on 01/12/2023: customer reported they pulled out the wire and dilator.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: sample analysis, patient severity, applicable previous investigation(s), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a knotted catheter is confirmed.One 5 fr dual lumen powerpicc solo ft with a 3cg stylet and one 5 fr microintroducer sheath were returned for evaluation.An initial visual observation showed use residue on the returned sample.A knot was observed in the catheter tubing approximately 1.6 cm proximal to the distal end of the catheter.A microscopic observation revealed biological residue within the folds of the knot in the catheter tubing.The knot in the distal end of the returned sample was likely caused by repeated advancement and retraction of the catheter against resistance within the vessel.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16261240
• Report Number: 3006260740-2023-00256
• Device Sequence Number: 4881217
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 1295108FD
• Device Lot Number: REGT3315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 03/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Sex: Unknown