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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported that when pre-flushing the catheter, the operator found that liquid leaks occurred at the site 2 cm from the valve at the proximal end of the catheter.No other information was provided.
Event or Problem Description
It was reported that when pre-flushing the catheter, the operator found that liquid leaks occurred at the site 2 cm from the valve at the proximal end of the catheter.No other information was provided.Additional information: it was reported the catheter was not used on the patient and there was no harm.
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 leaking catheter is confirmed and was determined to be use related.One 4 fr s/l groshong nxt clearvue catheter with its inlaid stylet was returned for evaluation.An initial visual evaluation revealed some use residues throughout the returned catheter.An observation of the returned video revealed the catheter to leak just proximal of the distal valve.The video showed someone flushing the catheter over its tray using a syringe.The catheter was visibly leaking in the video.A microscopic observation of the catheter revealed a small, circular hole just proximal of the distal valve of the catheter.The split was observed to be located just distal of the distal tip of the stylet.The catheter was subsequently split open to observe the inside surface of the split.No additional marks were observed on the inside of the catheter; however, the inside surface of the split had some impressions that appeared to come from the inside of the catheter to the outside of the catheter.Because of the location and shape of the observed split, the complaint of a leaking catheter is confirmed and is likely due to stylet damage.This complaint will be recorded for future trending and monitoring purposes.
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
It was reported that when pre-flushing the catheter, the operator found that liquid leaks occurred at the site 2 cm from the valve at the proximal end of the catheter.No other information was provided.Additional information: it was reported the catheter was not used on the patient and there was no harm.
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
It was reported that when pre-flushing the catheter, the operator found that liquid leaks occurred at the site 2 cm from the valve at the proximal end of the catheter.No other information was provided.Additional information: it was reported the catheter was not used on the patient and there was no harm.

• Brand Name: GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASIC
• 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: 17908769
• Report Number: 3006260740-2023-04603
• Device Sequence Number: 12673835
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(17)240630(10)REFU3906
• 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,Followup
• Report Date (Section B): 06/21/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: REFU3906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 01/26/2024; 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/16/2024; 06/18/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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