MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG® SINGLE LUMEN CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

The device(s) has not been received by the manufacturer for evaluation.A lot history review (lhr) review is not possible; as no manufacturing lot number(s) has been provided.Per 21 cfr part 803.56 not enough information has been provided about each identified patient and/or device mentioned.Therefore, one emdr is being submitted for multiple reportable events, identified in the literature search.[(b)(4)].

Event Description

Per thrombosis journal study: "the picc inserted is the groshong® single lumen closed ended catheter under ultrasound guidance using the sonosite nanomaxx® machine." (jones et al., 2017 p 2) " prdvt developed in 27 (5.5%) of the 490 patients in the cohort.Distant vte developed in 26 patients (5.3%).All-type vte (i.E.Prdvt or distant vte) was identified in 52 (10.6%) patients with one patient having a picc related dvt followed by a pe." (jones et al., 2017 p 3).Reference: jones, d., wismayer, k., bozas, g., palmer, j., elliott, m.And maraveyas, a.(2017).The risk of venous thromboembolism associated with peripherally inserted central catheters in ambulant cancer patients.Thrombosis journal, 15(1).Doi.Org/10.1186/s12959-017-0148-y.

• Brand Name: GROSHONG® SINGLE LUMEN CATHETER
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 8396889
• MDR Text Key: 138069520
• Report Number: 3006260740-2019-00475
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention