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

Model Number N/A

Device Problems Component Incompatible (1108); Misassembled (1398)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refv2000 showed four other similar product complaint(s) from this lot number.

Event Description

It was reported that the catheter was unable to pass through the oversleeve.When the inside of the oversleeve was checked, it was confirmed that the catheter was broken in the oversleeve.There was no reported patient injury.It was reported this occurred with two devices.This report addresses the first device.

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, 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 difficulty assembling the catheter/connector system was confirmed.The product returned for evaluation was one 4fr s/l groshong connector.The sample comprised the distal segment.The proximal segment was not returned for evaluation.A segment of catheter shaft was visible within the clear strain-relief sleeve.Following longitudinal bisection of the sample, inspection of the compression sleeve revealed that it contained a fragment of catheter shaft and had been advanced nearly entirely into the narrow region of the bore.Microscopic inspection compression sleeve confirmed that it was advanced too far into the narrow region of the bore.The catheter fragment was compressed and folded within the sleeve.Mechanical damage was observed at the proximal region of the sleeve.The end of the catheter was roughly aligned with the compression sleeve.The catheter alignment indicated that the catheter had not been fully inserted through the distal connector segment during catheter/connector assembly.The catheter was compressed and folded within the compression sleeve because the compression sleeve had been too far advanced into the narrow region of the connector bore.The mechanical damage suggested that connector cannula may have caught on the compression sleeve, causing it to be inserted too far into the distal connector segment.Such damage may be avoided if the catheter is passed entirely through the distal connector segment and advanced over the metal cannula prior to connector assembly.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the catheter was unable to pass through the oversleeve.When the inside of the oversleeve was checked, it was confirmed that the catheter was broken in the oversleeve.There was no reported patient injury.It was reported this occurred with two devices.This report addresses the first device.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14519968
• MDR Text Key: 292793499
• Report Number: 3006260740-2022-01986
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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
• Device Lot Number: REFV2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other