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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Kinked (1339)

Patient Problem No Information (3190)

Event Date 08/16/2017

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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.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 damaged guidewire was confirmed, and the cause was unknown.One nitinol guidewire was returned for investigation.The guidewire was received in its hoop.The blue tip straightener was not returned for investigation.The overall length of the wire was 48.6cm, which indicates that 0.4cm ¿ 2.4cm of the wire was missing.The core wire was protruding through the side of the coil wire and 4mm of the core wire was exposed.The coil wire was not stretched or elongated.There was a kink in the coil wire where the core wire protruded through the coils.From the proximal end of the coil wire, the core wire extended 4.1cm.A microscopic examination of the distal end of both the coil and core wire revealed areas of increased luster adjacent to granular areas.The characteristics of the damage are consistent with the wire being severed with a sharp instrument.The weld tip was not present on the returned device.Since the distal end was missing from the guidewire, the complaint was confirmed and the damage appeared to be related to contact with a sharp instrument; however, since it was reported that the guidewire was noted to be damaged as soon as it was taken from the package, the cause was unknown.A lot history review (lhr) of rebn1442 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guide wire was taken from the package and it was noted that the tip was damaged.It was not used on a patient.(b)(6) 2017 - returned wire is kinked with the weld tip missing as observed in decontamination.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7087463
• MDR Text Key: 94144888
• Report Number: 3006260740-2017-02174
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• 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: REBN1442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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