MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Groshong CLEARVUE; Peripherally Inserted Central Catheter (PICC)

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/05/2026
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.
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.
Event or Problem Description
Additional information received 30-sep-2026;\ the issue with this case of picc has been resolved.Hcp informed that he was able to remove the picc using snare and no interventional procedure was needed for surgical removal of groshong picc line.\ patient is doing fine.They inserted a new groshong picc line in patient through other arm and the procedure went smooth without any complications.
Event or Problem Description
It was reported during picc insertion procedure, picc got stuck near clavicle in some vessel and was difficult to retrieve.The initial picc line is still inside the patient body.Patient is 3-4 year old child undergoing leukemia treatment.Hcp was not able to remove the picc line from the patient as it has got stuck in some vessel.They tried to remove it by pulling it back but it is not coming out as it stuck inside some vessel.Replacement of line could not be done, so they are giving chemo treatment through central line.Initially some resistance was felt during insertion but they pulled picc back a little and managed to insert it but then it got stuck in some vessel and did not move forward.Hcp said that they tried to pull the line back , but it was not coming out.They did fluro and usg to locate the picc position where it is stuck in vessel.They flushed the catheter, tried to manipulate using stylet but then stylet perforated the picc, so, they abandoned the procedure and inserted central line to continue treatment.Hcp informed that they are evaluating other options if they can remove picc or perform surgery for picc removal.

• Brand Name: Groshong CLEARVUE
• Common Device Name: Peripherally Inserted Central Catheter (PICC)
• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50874621
• Report Number: 3006260740-2026-06962
• Device Sequence Number: 13440605
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272(11)260212(17)290430(10)RELN1801
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K034020
• 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
• Report Date (Section B): 09/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: RELN1801
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• 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