MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 per-q-cath catheter.The sample was received with an inlaid stylet and attached t-lock assembly.The stylet exhibited multiple bends just proximal of the t-lock assembly.Another bend was observed between the 58cm and 59cm depth markings.Blood residue was observed on the outside of the stylet.Microscopic inspection of the sample confirmed bends in the stylet and the presence of blood residue but was otherwise unremarkable.The deformation was consistent with stylet manipulation, including possible attempts to feed the stylet through the t-lock assembly septum.The blood residue suggested that manipulation occurred during attempted device use.Evaluation findings are in section h.11.
Event or Problem Description
It was reported that upon opening of the midline¿s package, the proximal end of the guide wire inside was found bent.It was not sure if the catheter was damaged or not.The product was therefore unusable.(b)(6) 2023 - the customer reported a bent guidewire however a stylet was returned for evaluation and exhibited multiple bends.

• Brand Name: PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16950903
• Report Number: 3006260740-2023-01940
• Device Sequence Number: 7012809
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954104
• 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
• Report Date (Section B): 05/10/2023

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 4134105
• Device Lot Number: REES2344
• 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: 05/09/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• 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