MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG CATHETER; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
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 that on (b)(6) 2025, a client from the urology department inserted a picc line into a patient.Upon visualizing green waves on the ultrasound screen at the target position, the client retrieved the inner guidewire from the catheter.While subsequently retracting the catheter by one centimeter, the catheter suddenly fractured.The technician immediately applied a tourniquet to the upper arm and notified the interventional radiologist.The physician performed an interventional retrieval procedure to extract the broken tubing.No further details available or 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 catheter break is confirmed but the root cause could not be determined.One photograph of a groshong tubing segment was returned for evaluation.Inspection of the photograph found that a segment of catheter tubing, between the 50 cm and 60 cm depth markers was present, resting atop a surface.The tubing had an angled fracture edge at both ends.No other features of the break could be discerned based on the photo.Based on the available material for review, the complaint is confirmed but there is insufficient evidence to identify the root cause.This complaint will be recorded for future trending and monitoring purposes.
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 catheter break was confirmed.The product returned for evaluation was a segment of 4fr sl groshong catheter tubing.Additionally, one photograph was also submitted by the complainant for review.No additional information was observed in the photograph which changed the conclusion of the investigation.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a break was observed on the catheter tubing between the 50 cm and 51 cm depth markers.Microscopic examination of the break confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: ¿ the fracture surface contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.¿ sharply formed fracture edges 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.

• Brand Name: GROSHONG CATHETER
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23526975
• Report Number: 3006260740-2025-08558
• Device Sequence Number: 13312573
• Product Code: LJS
• UDI-Device Identifier: 00801741035326
• UDI-Public: (01)00801741035326(11)250506(17)270831(10)REKQ1438
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7717405
• Device Lot Number: REKQ1438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 12/29/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/19/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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: Required Intervention
• Patient Sex: Unknown