MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 91660417

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

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

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebv2238 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebv2238) have been reported from the same facility.

Event Description

It was reported that the rn paid close attention to flushing the line before insertion and manipulating the wire to ensure it wasn't stuck in the device.Nurse noticed that ¿it felt sticky¿.When trying to remove the wire, it began ¿bunching¿.Picc was inserted without incident.No injury to patient or staff.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of difficulty removing the inlaid stylet was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs depicting the proximal end of a groshong catheter.The distal end of the catheter appeared to be placed within a patient.All three photographs depicted the proximal end of the catheter overlaying the stylet flushing connector cannula.Proximal end of the catheter appeared to be bunched and compressed distal of the cannula.All three photographs depicted catheter bunching consistent with difficult stylet removal; however, inspection of those photographs was insufficient to identify the cause of that difficulty.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include stylet damage and residue bonding the stylet to the catheter.A lot history review (lhr) of rebv2238 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebv2238) have been reported from the same facility.

Event Description

It was reported that the rn paid close attention to flushing the line before insertion and manipulating the wire to ensure it wasn¿t stuck in the device.Nurse noticed that ¿it felt sticky¿.When trying to remove the wire, it began ¿bunching¿.Picc was inserted without incident.No injury to patient or staff.

• Brand Name: GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7234075
• MDR Text Key: 98880139
• Report Number: 3006260740-2018-00085
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741107825
• UDI-Public: (01)00801741107825
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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 Catalogue Number: 91660417
• Device Lot Number: REBV2238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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