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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an incident that occurred on 30th october with the groshong dual lumen "bursting".Two nursing staff were caring for the picc and flushed and aspirated both red and white lumens.On the second flush of white lumen, staff heard an audible "pop" and flush solution came out.The staff then clamped with artery forceps and reported issue.Picc has since been removed and replaced.Upon further questioning, i was able to clarify that there was no patient impact other than delay in treatment and replacement of picc line.It was confirmed with staff member present at the time that a 10ml syringe was used and there was no obvious resistance.
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
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 split is confirmed; however, the exact root cause could not be determined.One photograph of a dual lumen groshong catheter was returned for evaluation.An initial visual observation of the photograph showed the catheter in a clear, plastic bag.A split was observed in the extension tube of the white lumen.No further details of the split site could be discerned in the returned photograph.There were no distinguishing features which could aid in identifying a specific root cause of the split.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
Additional information 12/16.During the flushing process of the picc lines (patient has a dual lumen groshong picc), one of the picc lines (white lumen) burst upon flushing.Initially flushed the red lumen first with no resistance and back flow, then went on to flush the white lumen.Flash back occurred; no resistance was felt according to the nurse on flushing.Able to pulsate once, then on second pulsation the picc burst., making a popping sound.Patient did not feel any pain or discomfort during this.The picc line being double lumen, could not be accessed and needed to be changed.Burst line quickly clamped whilst situation investigated.Contacted dr who ordered for a new picc to be inserted.Contacted radiology who could not schedule an urgent insertion due to near closing time.Scheduled for friday 1330hrs (b)(6) 2025.In mean time, reverted back to ivc with 4hrly benzopenicillin 1.8g order with nurse who was working in radiology at the time kindly came up and inserted cannula after inspecting the picc line.Current picc line removed which measured 45cm with end tip saved.Compared to original cvad chart which also measured 45cm.Both nurses are both trained in picc lines and had completed her online picc course training has had previous experience with flushing piccs already.Has cared for picc of other patient currently on our ward with no issues.There was no previous issues raised with this picc that had been inserted (b)(6) 2025.A 10ml syringe was used.
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.

• Brand Name: GROSHONG NXT CLEARVUE
• 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: 23773544
• Report Number: 3006260740-2025-09528
• Device Sequence Number: 6023439
• Product Code: LJS
• UDI-Device Identifier: 00801741035388
• UDI-Public: (01)00801741035388
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 01/06/2026

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 Model Number: N/A
• Device Catalogue Number: 7857505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 01/06/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/06/2026; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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