MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 5FDL REVERSE TAPER PICC BASIC TRAY W/MICROINTRODUCER 45CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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	04/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rees3128 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "groshong picc was inserted in radiology.Patient was sent back to surgical ward after insertion.Ward medical officer was about to start treatment for this patient.While he was checking patency, he found that there was leaking at the proximal hub.He stopped the procedure.".
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a catheter leak is confirmed but the exact cause remains unknown.One video sample of a 5 fr groshong dl catheter was provided for evaluation.The catheter is shown within patient use and is secured with a statlock securement device.The catheter is being manipulated to bend the catheter at the region that extends from the bifurcation hub.A spraying leak is noted at the proximal portion of the catheter where the interface is located with the hub.The characteristics of the damage on the catheter could not be closely inspected from the video sample provided.Since the presence of a leak was observed in the video provided, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that "groshong picc was inserted in radiology.Patient was sent back to surgical ward after insertion.Ward medical officer was about to start treatment for this patient.While he was checking patency, he found that there was leaking at the proximal hub.He stopped the procedure.".

• Brand Name: GROSHONG NXT 5FDL REVERSE TAPER PICC BASIC TRAY W/MICROINTRODUCER 45CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14316610
• Report Number: 3006260740-2022-01662
• Device Sequence Number: 5224069
• Product Code: LJS
• UDI-Device Identifier: 00801741035388
• UDI-Public: (01)00801741035388
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 7857505
• Device Lot Number: REES3128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• 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