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	Misassembled (1398); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, on (b)(6) 2025 the patient with picc in place was admitted to the hospital and was found to be oozing medication during infusion.Upon inspection by the charge nurse it was found that there was no catheter present at the puncture point and only the external extension tubing and connector was fixed outside the patient's body.The hospital then inspected the extension tubing decompression sleeve on its own, which may have damaged the decompression sleeve.
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 it 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.
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 catheter break was confirmed.The product returned for evaluation was one 4fr sl groshong nxt catheter.A gross visual inspection of the catheter found that dents were present on the proximal connector locking arms and distal connector.Based on the event description, it is likely that this damage was caused by manipulation by the customer after the reported event.Further inspection of the returned sample found that use residue was present and that no portion of the catheter tubing was visible.The two-piece connector was disassembled and a portion of catheter tubing was found threaded over the proximal connector cannula.The catheter tubing had a complete fracture, occurring away from the tip of the connector cannula.Circumferential deformation of the catheter tubing was observed near the fracture site, such that the tubing had a bowed appearance.The appearance of the deformation likely indicated that the tubing had been bunched up inside the two-piece connector.Inspection of the break site found that the fracture edges were uneven/ jagged and the fracture surface was granular, both features consistent with tensile stress.Based on the available evidence, it is likely that the catheter tubing was bunched up inside the connector, causing weak points and material stress to develop, and eventually propagating into a complete break.Bunching up of the tubing may occur due to excessive force or manipulation of the catheter tubing during threading of the catheter through the distal two-piece connector.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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21810059
• Report Number: 3006260740-2025-02202
• Device Sequence Number: 18386042
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(11)240417(17)261031(10)REJP2067
• 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,Followup
• Report Date (Section B): 06/16/2025

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: 7715405
• Device Lot Number: REJP2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 06/16/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/09/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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