MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIC JAPAN HANG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rees0525 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that air contamination was found during aspiration.There was no reported patient injury.

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, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the catheter was confirmed but the cause is unknown.The product returned for evaluation was an assembled proximal and distal two-piece connector from a 4fr s/l groshong nxt catheter.The distal catheter shaft was not returned for evaluation.The connection between the proximal and distal pieces appeared tight, with the locking arms engaged within the grooves.No breaks or splits were noted in the returned section of the device under gross visual examination.However, when microscopic examination was conducted, a small piece of groshong catheter (0.39¿ long) could be seen within the two-piece connector.This indicated that the tubing broke rather than dislodged.The distal end of the catheter segment was jagged, and it contained a dull finely granular surface.The wall thickness of the catheter was measured, and it was confirmed that the catheter wall thickness met the device specifications.No molding defects were seen along the inner bore of the distal piece of the two-piece connector.The distal end of the proximal piece cannula appeared properly radiused and void of slivers or burrs.The length and outer diameter of the cannula met the device specifications.Although it could be confirmed that the catheter had broken, the exact cause could not be determined at this time.Possible contributing factors include tensile (pulling) damage, catheter wear on the proximal piece cannula, catheter damage due to improper connection of two-piece connector (e.G.Catheter kinked on cannula during assembly), mechanical stresses, or material fatigue.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that air contamination was found during aspiration.There was no reported patient injury.

• Brand Name: GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIC JAPAN HANG
• Type of Device: 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
• MDR Report Key: 10907234
• MDR Text Key: 218957863
• Report Number: 3006260740-2020-20684
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7617405J
• Device Lot Number: REES0525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other