MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PROV 4F DL IR 135CM NI; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S3274335
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, catheter was placed at one facility and cracked while patient was at a different facility.There was no negative impact or harm and the catheter was removed and replaced.
Additional Manufacturer Narrative
H11: section a through: 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 is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer, catheter was placed at one facility and cracked while patient was at a different facility.There was no negative impact or harm and the catheter was removed and replaced.
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 cracked catheter was confirmed.The product returned for evaluation was one 4fr dl powerpicc sv catheter.A gross visual inspection of the returned unit found that a longitudinally aligned tear was present on the catheter tubing between the 3 cm and 5 cm depth markers.At the tear site was deformation of the catheter tubing cross-section, giving the tubing an oblong shape.The tear was aligned along the 'peak' of the oblong shape where the degree of curvature was higher.Microscopic inspection of the tear site found that the fracture had rounded edges and a granular surface.Both features indicative of tensile stress.A portion of the tear at the proximal end did not fully penetrate the catheter wall.This feature suggested that the tear began on the exterior of the tubing and propagated inward, a feature which is indicative of compression induced damage.Based on the observed features, it is likely that the unit experienced compression damage, leading to tensile stress to form along the points in the catheter tubing where the degree of curvature was higher and eventually forming into a fracture.

• Brand Name: PROV 4F DL IR 135CM NI
• 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20537415
• Report Number: 3006260740-2024-06224
• Device Sequence Number: 17835947
• Product Code: LJS
• UDI-Device Identifier: 00801741130045
• UDI-Public: (01)00801741130045(11)240722(17)251231(10)REJS4676
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 12/31/2025
• Device Catalogue Number: S3274335
• Device Lot Number: REJS4676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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