MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SLIM-CATH STRAIGHT SHORT-TERM DIALYSIS; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during placement of cvc, it was found that the j wire was partially unraveled at about 5cm from the j.No metal was ever in contact with the j wire.Potential equipment malfunction versus shearing of the j wire at the tip of the microintroducer catheter." patient harm: the patient suffered emotional distress or inconvenience.
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regp0333 showed no other similar product complaint(s) from this lot number.
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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed; however, the exact cause is unknown.One 0.035 in.¿j¿-tipped guidewire in a plastic hoop was returned for evaluation.An initial visual observation showed use residue on the returned sample.Damage was observed in the coiled wire of the guidewire about 4.3 cm proximal to its distal tip.Tactile evaluation of the guidewire confirmed the core wire was not broken.A microscopic observation revealed the coiled wire of the guidewire was disjointed and slightly unraveled at the location of the damage.The weld tips of the guidewire were observed to be present and intact, and no other damage was observed on the returned sample.While the exact cause of the damage in the returned guidewire could not be determined, possible causes include damage during handling or use.H3 other text: evaluation findings are in section h.11.
Event or Problem Description
It was reported "during placement of cvc, it was found that the j wire was partially unraveled at about 5cm from the j.No metal was ever in contact with the j wire.Potential equipment malfunction versus shearing of the j wire at the tip of the micro introducer catheter." patient harm: the patient suffered emotional distress or inconvenience.

• Brand Name: POWER-TRIALYSIS SLIM-CATH STRAIGHT SHORT-TERM DIALYSIS
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• 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: 14860536
• Report Number: 3006260740-2022-02458
• Device Sequence Number: 12089750
• Product Code: NIE
• UDI-Device Identifier: 00801741107177
• UDI-Public: (01)00801741107177
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 5855240
• Device Lot Number: REGP0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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