MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by the customer that there was something within the picc when trimming.This required a 2nd picc to complete the procedure.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 complaint of trimming the stylet inside a powerpicc catheter is confirmed and was determined to be use-related.One 4 fr s/l powerpicc with its inlaid stylet and t-lock extension set was returned for evaluation.An initial visual observation revealed the catheter was returned cut at the 36 cm depth marker.The distal fragment of catheter from the 36 cm depth marker to the distal end of the catheter was returned for examination.The stylet was returned partially sticking out of the distal end of the catheter.The warning tag was returned attached to the t-lock assembly of the device.A functional test of attempting to infuse water into the catheter using a 12 ml syringe revealed the catheter was patent to infusion, and no foreign material was observed to be exiting the catheter.A functional test of attempting to infuse water into the distal fragment of catheter using a 12 ml syringe revealed the distal fragment of catheter was patent to infusion with no foreign material observed to be exiting the device.A microscopic observation revealed the returned stylet was cut at the distal end of the stylet.The cut stylet appeared to have an overall elliptical shape at the distal end of the stylet.The fracture surface of the break appeared flat on one side of the surface and uneven on the opposite side of the fracture surface.Because the stylet was observed to be cut without the distal end of the stylet returned, the potential foreign material found inside the powerpicc was likely the missing distal stylet fragment.The warning label returned on the device warns not to cut the stylet.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that there was something within the picc when trimming.This required a 2nd picc to complete the procedure.No other information was provided.

• Brand Name: POWERPICC CATHETER 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19060908
• Report Number: 3006260740-2024-01546
• Device Sequence Number: 6271658
• Product Code: LJS
• UDI-Device Identifier: 00801741101533
• UDI-Public: (01)00801741101533
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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,Followup
• Report Date (Section B): 06/25/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000443
• Device Lot Number: REHV2264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: 57 YR
• Patient Sex: Unknown