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

Model Number	N/A
Medical Device Problem Codes	Suction Problem (2170); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, after placing our groshong picc (model 7717405) catheter, the next day, the liquid did not drip, through a variety of troubleshooting, this situation still occurs, and then decided to pull out the catheter in vitro inspection, did not find any residues of drugs in the catheter and blood stagnation and other foreign objects, connected to the syringe injection smooth, but connected to the infuser, the infuser bottle elevated and then did not drip, sales was aware of this and went to check it by briefly folding back to loosen the infusion tube, the liquid does not drip, and then force to the infusion bottle after the pressure of the liquid can drip, and then turn off the infusion device and then open the situation does not drip, suspected that the pressure at the tip of the catheter three-way valve than the pressure of other normal use of the catheter to be greater, resulting in the liquid can not be dripped within the normal range of pressure.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 patency difficulties was confirmed; however, the exact cause was unknown.The product returned for evaluation was one groshong picc.The catheter was received assembled onto the two-piece connector.A microscopic observation revealed some use residue within the returned catheter adjacent to the valve, but no damage was observed on the returned sample and the valve length was measured and found to be within specification.Repeated functional flow tests of the catheter concluded that the groshong valve did not open for aspiration as intended.Infusion tests were successful, but the catheter would not aspirate.Following initial valve aspiration testing, the valve was re-lubricated with silicone oil and additional aspiration testing confirmed aspiration.Because application of silicone lubricant established proper valve function, it is likely that a lack of lubricant contributed to the reported event.It is unknown if the lubricant applied during manufacture was affected by the clinical procedure or if the lubricant was affected prior to attempted device use.Therefore, the root cause of the patency difficulties is unknown.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: GROSHONG PICC
• 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: 21360732
• Report Number: 3006260740-2025-00541
• Device Sequence Number: 8452848
• Product Code: LJS
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(11)240514(17)261031(10)REJQ1763
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871080
• 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): 05/08/2025

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: 7717405
• Device Lot Number: REJQ1763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: Other
• Patient Sex: Unknown