MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the catheter was fractured on march 14, 2019.When the removed catheter was confirmed, the material was weaker than the usual catheter, and it was easily fractured by pulling a little.There was no reported patient injury.
Additional Manufacturer Narrative
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 broken catheter was confirmed, and the cause appeared to be use-related.The product returned for evaluation was one 5fr d/l groshong catheter.Usage residues were observed throughout the sample.The sample was received in two segments which shared a complete break between the 47cm and 48cm depth markings.Curved shape memory was observed near the break site.Tactile inspection of the sample revealed severe tensile weakness, material necking and discoloration in the vicinity of the break.Microscopic inspection of the break site revealed a coarsely granular fracture surface.The catheter exhibited an elliptical cross-section.The fracture features and surrounding material features were consistent with material failure under tensile (pulling) stress.Catheter securement, maintenance and access techniques may have contributed to the damage.A lot history review (lhr) of recv2073 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was fractured on (b)(6) 2019.When the removed catheter was confirmed, the material was weaker than the usual catheter, and it was easily fractured by pulling a little.There was no reported patient injury.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8505002
• Report Number: 3006260740-2019-00852
• Device Sequence Number: 11251694
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: RECV2073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1