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	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet received.
Event or Problem Description
It was reported that just after placement of the groshong catheter, medical solution could not be infused.Therefore, the catheter was removed.There was no reported patient injury.
Event or Problem Description
It was reported that just after placement of the groshong catheter, medical solution could not be infused.Therefore, the catheter was removed.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 an occluded 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.Caps were attached to both luer adapters and the sliding suture wing was fixed between the 35cm and 38cm depth markings.Microscopic inspection of the sample revealed abundant biological residue adhered within both valves.An attempt to infuse water through both lumens revealed them to be fully occluded, apparently by biological residues.Occlusion of both lumens was observed, and the occluding material appeared to be blood product accumulation/coagulation.It appeared that the occlusion was caused by improper catheter maintenance, resulting in blood product being left in both lumens.The product ifu provides guidance pertaining to proper catheter maintenance.

• 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: 8575768
• Report Number: 3006260740-2019-01269
• Device Sequence Number: 19265308
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1