MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY; 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	01/24/2022
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) 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.After (b)(6) 2022, it was not used for medicine administration, and the catheter was maintained by flushing with saline solution once a week.On (b)(6) 2022, when the catheter was started using by connecting it to the lumen of the white luer connector to start chemotherapy, an alarm to notify catheter occlusion sounded.Therefore, when the catheter was flushed with saline solution, leakage occurred near the 52cm depth marking on the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.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.After (b)(6) 2022, it was not used for medicine administration, and the catheter was maintained by flushing with saline solution once a week.On (b)(6) 2022, when the catheter was started using by connecting it to the lumen of the white luer connector to start chemotherapy, an alarm to notify catheter occlusion sounded.Therefore, when the catheter was flushed with saline solution, leakage occurred near the 52cm depth marking on the catheter.There 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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 4fr s/l groshong catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed at the 52cm depth marking.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear.'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.
Event or Problem Description
It was reported that the patient had a groshong catheter implanted on (b)(6) 2021.After (b)(6) 2022, it was not used for medicine administration, and the catheter was maintained by flushing with saline solution once a week.On (b)(6) 2022, when the catheter was started using by connecting it to the lumen of the white luer connector to start chemotherapy, an alarm to notify catheter occlusion sounded.Therefore, when the catheter was flushed with saline solution, leakage occurred near the 52cm depth marking on the catheter.There was no reported patient injury.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13482854
• Report Number: 3006260740-2022-00201
• Device Sequence Number: 5462381
• 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
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 7927505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/31/2022
• 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 Sex: Unknown