MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY); CATHETER, PERCUTANEOUS

Catalog Number 7715435CE

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

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

Event Date 10/07/2017

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) of rebr0320 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (rebr0320) have been reported from the same facility.

Event Description

It was reported that the device was defective and there is leakage.No reported patient injury.This file addresses device three of three.

• Brand Name: GROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY)
• Type of Device: CATHETER, PERCUTANEOUS
• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 6998034
• MDR Text Key: 91222703
• Report Number: 3006260740-2017-01955
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

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 Catalogue Number: 7715435CE
• Device Lot Number: REBR0320
• 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: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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
• Patient Age: 32 YR
• Patient Weight: 56