MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1193108D5
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
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 failure was found during evaluation of a returned sample.  additional investigation is required to determine the cause of the failure.Results of the investigation are expected soon.
Event or Problem Description
It was reported by the customer that the "ecg wire bent within picc line." additional information 01/24/2023: it was reported by the customer "had to open a new provena picc kit due to malfunctions of line.Picc line never touched the patient." 4/20/2023: the returned device was confirmed to be a bent stylet.
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a bent stylet was confirmed.The product returned for evaluation was one 4fr s/l powerpicc solo catheter.The catheter was received with an inlaid 3cg tls stylet with attached t-lock assembly.The catheter was trimmed near the 40cm depth marking.The stylet extended several centimeters past the tip of the catheter.A bend was observed in the stylet near the transition to the plastic-coated region.The stylet appeared to be intact.Microscopic inspection of the sample revealed biological residue visible on both the catheter and stylet.The bend in the stylet appeared to be caused by device manipulation.Such damage may easily occur if the stylet is inserted past the tip of the catheter prior to catheter insertion, which appeared consistent with the position of the stylet and accompanying biological residues.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer that the "ecg wire bent within picc line." additional information 01/24/2023: it was reported by the customer "had to open a new provena picc kit due to malfunctions of line.Picc line never touched the patient." (b)(6)2023: the returned device was confirmed to be a bent stylet.

• Brand Name: POWERPICC 3F SL SOLO MAX BARRIER PLUS KIT
• 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: 16921586
• Report Number: 3006260740-2023-01840
• Device Sequence Number: 6719728
• Product Code: LJS
• UDI-Device Identifier: 00801741155185
• UDI-Public: (01)00801741155185
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 01/31/2024
• Device Model Number: S1193108D5
• Device Catalogue Number: S1193108D5
• Device Lot Number: REGX2295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 115 KG