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

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
Bd medical services received the following via phone call: doctor states he just placed a powerpicc in a patient.Doctor states he trimmed the catheter while the wire was still in.When he removed the wire, it was still 50cm in length so no wire was left in the patient however it appears some of a coating was shaved off and is inside the catheter in the patient.Doctor is asking for the material of the coating or if we know how floppy it is to know if he would be able to remove it with a snare.Bd medical services responded "informed doctor the powerpicc kit contains a flexura nitinol guidewire.The material is nitinol and is not coated.Informed doctor unsure what "coating" would have came off or if the wire itself was shaved off.Informed doctor we have no information regarding a potential shaving of the guidewire in a patient and removing it or if he should replace the entire catheter.How to proceed is a clinical decision.Additional information 3/19 during follow up phone call with customer: ¿"fixed the problem: 2 comments has stifler wiring.Forgot to pull the wire back before cutting, cutting the outer sheath off of it.The wire too short to act as lead wire.Advanced stifller wire to insert catheter and caught distal end of end and sheath broke off.Surgeon removed the end of the sheath." catheter was flushed prior to removing the stylet.No adverse effects to the patient.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK TLS TECH 5F MAX
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16644335
• Report Number: 3006260740-2023-01055
• Device Sequence Number: 6061087
• Product Code: LJS
• UDI-Device Identifier: 00801741035692
• UDI-Public: (01)00801741035692
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 9275108D
• Device Lot Number: REGW2251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown