MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 5F DL REVERSE TAPER BT SAFETY INTRODUCER (55CM); 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	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the patient had a groshong catheter implanted on (b)(6) 2021 that leaked medicine near the catheter connector.Therefore, the device was removed from the patient's body.Three was no reported patient injury.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed.One 5 fr dual lumen groshong nxt catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.Both lumens of the returned catheter were flushed with a 12 ml syringe of water.The proximal (red) lumen was found to be patent to infusion and aspiration and no leaks were found when this lumen was flushed and pressurized.A spraying leak was observed just distal to the strain relief when the distal (white) lumen was flushed, and the distal lumen was found to be occluded, likely with biological residues.Tensile weakness was observed in the catheter around the leak site.A microscopic observation revealed a small, longitudinal split in the catheter at the leak site.The split was observed to be somewhat ¿s¿-shaped with clean edges and a smooth but granular texture on the fracture surfaces.The observed characteristics of the split found in the returned catheter, as well as the observed occlusion and presence of tensile weakness around the leak site, indicate burst damage caused by over-pressurization of the catheter.The product ifu states: ¿do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿.
Event or Problem Description
It was reported that the patient had a groshong catheter implanted on april 26, 2021.The proximal part of the catheter could not be infused the medicine.The next week improved, however, the distal part of the catheter could not be infused the medicine and the catheter occlusion continued.After that, the medicine leaked near the catheter connector.Therefore, the device was removed from the patient¿s body.There was no reported patient injury.

• Brand Name: GROSHONG NXT 5F DL REVERSE TAPER BT SAFETY INTRODUCER (55CM)
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12666616
• Report Number: 3006260740-2021-04427
• Device Sequence Number: 4211818
• Product Code: LJS
• UDI-Device Identifier: 00801741035401
• UDI-Public: (01)00801741035401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: 7927505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/08/2021
• 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 Age: 17 YR
• Patient Sex: Male