MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2019

Event Type  malfunction  

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 Description

It was reported that infusion could not be performed during administration using the groshong catheter.It was further reported that when the physician attempted to infuse forcedly, the catheter ballooned.There was no reported patient injury.

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 inability to infuse through the catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l groshong catheter.The sample was received assembled with a two-piece connector.Usage residues were abundant throughout the sample and the catheter tubing appeared to be full of coagulated blood products.Microscopic inspection of the valve w2as unremarkable.Inspection of the sample confirmed the presence of abundant blood product material within the catheter lumen.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be fully occluded, apparently by the observed blood products.The catheter appeared to be fully occluded by coagulated blood products, suggesting that improper catheter maintenance lead to the reported inability to flush the sample.The product ifu provides guidance for catheter maintenance and for dealing with blood product occlusions.

Event Description

It was reported that infusion could not be performed during administration using the groshong catheter.It was further reported that when the physician attempted to infuse forcedly, the catheter ballooned.There was no reported patient injury.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)
• Type of Device: 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: 8785224
• MDR Text Key: 150969884
• Report Number: 3006260740-2019-01936
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7655405J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1