MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER; CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2024, the icu department placed a groshongpicc catheter in the patient and was treated in the icu.On (b)(6) 2024, the patient's family found swelling in the patient's arm on the side where the catheter was placed, and reported it to the head nurse.Afterwards, they checked the picc catheter and found that it was in the icu.Leakage was found about 2cm from the puncture point toward the proximal end, and the catheter was ruptured.Patient was extubated.No other information was 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 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.The complaint of a damaged catheter is confirmed; however, the exact cause is unknown.One video of a groshong catheter was returned for evaluation.An initial visual observation of the video showed that as the catheter was flushed, a clear liquid sprayed out onto a napkin placed below.Use residue was observed on the sample in the returned video, but no details of the apparent damage could be seen.There were no distinguishing features in the returned video of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported on (b)(6) 2024, the icu department placed a groshongpicc catheter in the patient and was treated in the icu.On thursday, (b)(6) 2024, the patient's family found swelling in the patient's arm on the side where the catheter was placed, and reported it to the head nurse.Afterwards, they checked the picc catheter and found that it was in the icu.Leakage was found about 2 cm from the puncture point toward the proximal end, and the catheter was ruptured.Patient was extubated.No other information was provided.

• Brand Name: GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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 garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20048473
• Report Number: 3006260740-2024-04630
• Device Sequence Number: 12746153
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(11)221208(17)250930(10)REGX3240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: REGX3240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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