MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
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 be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that vascular access nurse placed this powerglide catheter inside a patient, when they flushed the catheter, there was leakage out from a small perforation at the junction between the catheter and catheter hub.This resulted in them having to place another powerglide in the patient, another insertion/poke for the patient.No other information was provided.
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 complaint of a leak in the catheter was confirmed.The product returned for evaluation was one 10 cm catheters from a 20 ga powerglide pro.The investigation findings are consistent with catheter damage caused by contact with a sharp-edged instrument, likely the integrated introducer needle.The returned product sample was evaluated and a hole in the catheter was observed towards the proximal end of the catheter.Microscopic examination of the catheter hole confirmed it was typical of contact with a needle, and the characteristics observed which supported this type of failure included: ¿ the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on the bevel of a needle.¿ the fracture edges were sharply formed and had planar (flat) surfaces.¿ the damage also contained the overall shape of a chevron 'v'.This shape is common to many needle bevels, and this shape is often transferred onto the catheter when punctured by a needle.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that vascular access nurse placed this powerglide catheter inside a patient, when they flushed the catheter, there was leakage out from a small perforation at the junction between the catheter and catheter hub.This resulted in them having to place another powerglide in the patient, another insertion/poke for the patient.No other information was provided.

• Brand Name: BASIC KIT 20G X 10 CM WITH BIOPATCH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: 20038349
• Report Number: 3006260740-2024-04591
• Device Sequence Number: 15051783
• Product Code: FOZ
• UDI-Device Identifier: 00801741140532
• UDI-Public: (01)00801741140532(11)231006(17)250131(10)REHV1923
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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): 10/16/2024

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: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F320107T
• Device Lot Number: REHV1923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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