MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 2F INTERMEDIATE TRAY (SINGLE-LUMEN) (30 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz3620 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported at the moment of placing the catheter, everything seems to be fine, however, after a short time the perqcath catheter breaks off the distal fragment for no apparent reason, a gummy consistency is observed in the lumen when it is removed."additional information received on oct 24 2022: at what time during device use (ie insertion, infusion) did the rupture occur? a: being placed on the patient during drug infusion.Did any part of the catheter remain in the patient? regarding this question, was the complete catheter obtained? a: nothing was left inside the patient.If yes, was surgery required to remove the broken piece? a: no were all missing/broken parts recovered and accounted for? a: yes, it was broken into 2 pieces and the consistency of the device material became gummy.Long-term harm to the patient? a: none, just that a new device of a different brand requested by the treating physician had to be replaced.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the catheter was confirmed but the cause is unknown.A photograph and video of a 2fr s/l per-q-cath catheter shaft were returned for evaluation of this complaint.A complete break was seen in the catheter shaft.However, the characteristics of the break could not be clearly observed, and the proximal segment of the catheter was not visible in the photograph or video.In the video, the catheter was longitudinally pulled, revealing that the material stretched easier and farther than typical which was consistent with the report that the catheter consistency had changed.The change in catheter consistency and catheter break were likely due to tensile weakness from plastic deformation of the material due to tensile (pulling) forces.However, this could not be confirmed as the sole root cause without the receipt of the physical sample.Other potential contributing factors could include damage from catheter stabilization, damage from stylet removal, or over-pressurization of the catheter.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported at the moment of placing the catheter, everything seems to be fine, however, after a short time the perqcath catheter breaks off the distal fragment for no apparent reason, a gummy consistency is observed in the lumen when it is removed."additional information received on oct 24 2022: ¿ at what time during device use (ie insertion, infusion) did the rupture occur? a: being placed on the patient during drug infusion.¿ did any part of the catheter remain in the patient? regarding this question, was the complete catheter obtained? a: nothing was left inside the patient.¿ if yes, was surgery required to remove the broken piece? a: no ¿ were all missing/broken parts recovered and accounted for? a: yes, it was broken into 2 pieces and the consistency of the device material became gummy.¿ any long-term harm to the patient? a: none, just that a new device of a different brand requested by the treating physician had to be replaced.".

• Brand Name: PER-Q-CATH PLUS PICC 2F INTERMEDIATE TRAY (SINGLE-LUMEN) (30 CM)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15713858
• Report Number: 3006260740-2022-04261
• Device Sequence Number: 12417027
• Product Code: LJS
• UDI-Device Identifier: 00801741035203
• UDI-Public: (01)00801741035203
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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 Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 4132000
• Device Lot Number: REFZ3620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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