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	10/28/2025
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
On (b)(6) 2025, during picc line maintenance for a patient at the oncology department, a broken catheter was discovered.The catheter had been in place for one week.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 fractured segment.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 a catheter break was confirmed but the root cause could not be determined.The product returned for evaluation was one 4fr sl groshong catheter.A gross visual inspection of the returned catheter found that two complete fractures had occurred on the catheter tubing, one at the 40 cm depth marker and another between the 28 cm and 29 cm depth markers.Microscopic inspection of the fracture sites found that portions of both sites had striations on the fracture surface and angular edges, both features associated with sharp instrument damage.Additionally, both fracture sites also had portions of the site which had a granular pattern on the fracture surface and rounded fracture edges, both features associated with tensile stress.A review of the reported event suggested that some of the observed damage may have been caused by the interventional retrieval procedure performed by the user; however, it could not be determined which of the features were created by this procedure.Based on the available material for review, it is likely that a combination of sharp instrument damage and tensile stress contributed to the reported event; however, insufficient evidence was identified to determine when or how the damage occurred.Therefore, the root cause remains unknown.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: 23544986
• Report Number: 3006260740-2025-08639
• Device Sequence Number: 9531209
• Product Code: LJS
• UDI-Device Identifier: 00801741035326
• UDI-Public: (01)00801741035326(11)241119(17)270831(10)REJW3361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871998
• 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): 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: REJW3361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: Required Intervention
• Patient Sex: Unknown