MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT 5 FR D/L PICC 55 CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 7927505

Device Problem Torn Material (3024)

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

Event Date 11/03/2017

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Not yet returned.

Event Description

It was reported that the molded hub of the catheter was torn near the area where it connects to the statloc.The operator believes the cause or this tear was excessive force of some kind applied on the molded hub.No patient harm reported.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency 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 a leak was confirmed, and it appeared that the catheter was damaged during use.One 5fr d/l groshong picc was returned for investigation.The picc revealed evidence of use.Coagulated blood residue was observed behind the proximal valve at the distal end of the catheter.A suture wing was secured to the catheter over the 36 and 37 cm depth marks.Sutures had been tied through the holes in the suture wing.The printing was partially worn from the extension legs.Tears were observed in the molded bifurcation just proximal to the wings.A microscopic examination of the torn material revealed a jagged and granular surface.The proximal lumen of the catheter was exposed where the bifurcation was torn.A functional test revealed that fluid leaked from the proximal lumen where the bifurcation was torn.The evidence of use suggests that the tears in the catheter developed over time and could be associated with how the catheter was secured and how the device was handled during use.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 the molded hub of the catheter was torn near the area where it connects to the statlock.No patient harm reported.

• Brand Name: GROSHONG NXT 5 FR D/L PICC 55 CM BASIC KIT
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7070692
• MDR Text Key: 94129920
• Report Number: 3006260740-2017-02161
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035401
• UDI-Public: (01)00801741035401
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7927505
• Device Catalogue Number: 7927505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Nursing Home
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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