MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER W/ SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY; 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	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that introducer bent while being inserted.Made it through the skin before issue occurred.The patient was sedated in the or.When the introducer failed, a new kit had to be acquired from our office, resulting in the child being sedated much longer than desired.The patient as sedated a total of 45 minutes longer than necessary as a result of the introducer failing.Another limb had to be punctured as a result.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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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 bent microintroducer was confirmed and the root cause was determined to be use related.The product returned for evaluation was one 5.0fr microez microintroducer.A gross visual inspection of the returned unit found that the dilator and sheath were bent.Two bends were observed on the dilator, one near the distal end and one near the midpoint of the dilator.The sheath had a bend around the midpoint of the sheath which aligned with one of the bend locations on the dilator.Several areas of material buckling were observed on the proximal half of the sheath.The taper and radius of the distal end of the sheath were compared to a similar, non-complaint sample and the sheath tip appeared to have been properly formed.The dilator tip was inspected and no deformation or deficiencies were observed.The shape, location, and extent of the damage observed on the returned unit suggested that the microintroducer sheath was most likely damaged due to excessive insertion force and/or a steep insertion angle.Additionally, the lack of deformation to the tip of the device likely indicates that there was no difficulty piercing the vein.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that introducer bent while being inserted.Made it through the skin before issue occurred.The patient was sedated in the operating room.When the introducer failed, a new kit had to be acquired from our office, resulting in the child being sedated much longer than desired.The patient as sedated a total of 45 minutes longer than necessary as a result of the introducer failing.Another limb had to be punctured as a result.No other information was provided.

• Brand Name: POWERPICC FT CATHETER W/ SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY
• 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: 20633157
• Report Number: 3006260740-2024-06511
• Device Sequence Number: 12634653
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572(11)240213(17)250531(10)REJN0735
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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 Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1275108FD
• Device Lot Number: REJN0735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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 Age: 12 MO
• Patient Sex: Unknown