MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 04/17/2017

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 for evaluation.A lot history review (lhr) of reay0111 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reay0111) have been reported from the same patient.

Event Description

The patient reported that on (b)(6) 2017 she had a groshong cvc that became dislodged within 2 weeks of placement and the tpn she was receiving leaked out.Patient states she was hospitalized to replace device as well as receive iv antibiotics to prevent infection.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6974788
• MDR Text Key: 90850773
• Report Number: 3006260740-2017-01889
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741041563
• UDI-Public: (01)00801741041563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/24/2017

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 Model Number: N/A
• Device Catalogue Number: 6626954
• Device Lot Number: REAY0111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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): Hospitalization