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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
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 a crack was found on the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed and was determined to be use related.One 5 fr dual lumen groshong nxt catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.An approximately 3 mm long split was observed in the catheter about 6.2 cm distal to the bifurcation.Tensile weakness was observed in the catheter between the 48 cm and 53 cm depth marker.Both lumens of the catheter were flushed with a 12 ml syringe of water and the split was determined to be in the red lumen.Both lumens were found to be patent to infusion.A microscopic observation revealed the split in the catheter was large and ¿c¿-shaped with a fork at one corner.The fracture surfaces were observed to be flat but slightly angled and granular in texture.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.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 a crack was found on the catheter.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: 9548177
• Report Number: 3006260740-2019-04053
• Device Sequence Number: 11324177
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 12/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1