MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN) (65 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/28/2023
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported a picc catheter was placed and during the guidewire removal it unraveled during traction.It was needed to restart the procedure with a new catheter and new insertion materials.Additional information received 10 august 2023: the procedure lasted for another 30 minutes, beyond the scheduled time.The patient complained of pain while the guidewire was being removed, imaging tests were performed, and the current patient is clinically stable, with improvement in breathing patterns.There was no need to administer pain medication, as the pain resolved after removal of the guide wire.A chest x-ray was performed after the procedure to analyze whether there was any damage caused by the event.The patient would exchange the central venous catheter for the picc due to the indication time for permanence of the central venous catheter that had expired.The picc would be used for the infusion of venous solutions necessary for the maintenance of his life.There is no other relevant history or concomitant therapy.
Additional Manufacturer Narrative
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 this information, the following was concluded: the complaint of a damaged stylet is confirmed and was determined to be use related.The product returned for evaluation was a hydrophilic stiffening stylet.Complete breaks were observed in both the core and coil wires.The coil wire was severely elongated.The distal wire fragment including the weld tip was broken off and not returned.Microscopic inspection of the break in the core wire revealed a granular fracture surface and a tapered break profile.A region of increased luster was observed on the fracture surface of the core wire.Inspection of the break in the coil wire revealed a sharply defined fracture surface.One region of the coil wire fracture surface exhibited a glossy, striated fracture surface.The coil wire was not elongated in the vicinity of the fracture surface.The fracture features were consistent with sharp instrument damage which likely occurred during trimming of the catheter.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported a picc catheter was placed and during the guidewire removal it unraveled during traction.It was needed to restart the procedure with a new catheter and new insertion materials.Additional information received 10 august 2023: the procedure lasted for another 30 minutes, beyond the scheduled time.The patient complained of pain while the guidewire was being removed, imaging tests were performed, and the current patient is clinically stable, with improvement in breathing patterns.There was no need to administer pain medication, as the pain resolved after removal of the guide wire.A chest x-ray was performed after the procedure to analyze whether there was any damage caused by the event.The patient would exchange the central venous catheter for the picc due to the indication time for permanence of the central venous catheter that had expired.The picc would be used for the infusion of venous solutions necessary for the maintenance of his life.There is no other relevant history or concomitant therapy.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN) (65 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17597546
• Report Number: 3006260740-2023-03630
• Device Sequence Number: 17752314
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 01/22/2024

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REFQ3534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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 Age: 11 YR
• Patient Sex: Female
• Patient Weight: 48 KG