MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN); 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A lot history review (lhr) of refw2433 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the guidewire/stylet fell apart when removed.(b)(6) 2022: add info received: was there any harm to the patient/health worker? there was no harm to the professional or the patient.Was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc.)?.It was not necessary has there been blood or chemotherapy exposure to mucous membranes or skin? if yes, were post-exposure prophylactic actions taken? no what treatment was the patient undergoing? the catheter was passed due to the need for prolonged antibiotic therapy, but the catheter was not used (problem during passing).What was the access location? cubital fossa.
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 following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged stylet is confirmed.One stiffening stylet was returned for evaluation.An initial visual observation showed the core wire of the stylet was broken and the majority of the coiled wire was severely unraveled.About 1 cm of one end of the coiled wire was observed to remain tightly coiled but broken at its end.A microscopic observation revealed the fracture site of the core wire to be angled and peaked, and linear striations were observed leading up to the peak of the break.The break site at the end of the section of the coiled wire which was not unraveled was observed to be forked and angled.The other break sites of the coiled wire were observed to be mostly flat with the coiled wire curled tightly leading up to the break.The distal end of the stylet was observed to be missing.The observed characteristics of the break sites in the returned stylet are indicative of damage caused by a sharp instrument such as scissors.H3 other text : evaluation findings are in section h11.
Event or Problem Description
It was reported the guidewire/stylet fell apart when removed.05/27/2022: add info received: ¿ was there any harm to the patient/health worker? there was no harm to the professional or the patient.¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc.)? it was not necessary ¿ has there been blood or chemotherapy exposure to mucous membranes or skin? if yes, were post-exposure prophylactic actions taken? no ¿ what treatment was the patient undergoing? the catheter was passed due to the need for prolonged antibiotic therapy, but the catheter was not used (problem during passing) ¿ what was the access location? cubital fossa.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN)
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14717994
• Report Number: 3006260740-2022-02301
• Device Sequence Number: 16678051
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2022

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REFW2433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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: 15 YR
• Patient Sex: Male
• Patient Weight: 47 KG