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

Catalog Number	7717405
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that due to poor vascular elasticity, a picc line was placed in the patient's right upper limb per physician's orders.X-ray findings showed: superior vena cava.During infusion, the patient experienced recurrent swelling in the right upper limb.Ultrasound examination ruled out intravascular thrombosis.After excluding other factors, it was observed that right upper limb swelling only occurred following infusion.Following consultation with the family, the picc line was removed.Post-removal examination revealed damage at the distal end of the catheter.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.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 leak is confirmed; however, the exact cause is unknown.One photograph of a groshong catheter was returned for evaluation.An initial visual observation of the photograph showed the device held in hand by a clinician.A droplet of clear liquid was observed on the catheter tubing.No details of the split site in the tubing could be discerned.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: GROSHONG CATHETER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24381794
• Report Number: 3006260740-2026-00930
• Device Sequence Number: 10490165
• Product Code: LJS
• UDI-Device Identifier: 00801741035326
• UDI-Public: (01)00801741035326
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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 Catalogue Number: 7717405
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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