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

Model Number 7715435

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

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 rebn0382 showed no other similar product complaint(s) from this lot number.The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported by ms&s that nurse called and stated she was in the middle of a procedure placing a groshong midline.When she opened the kit, the kit within the kit that contains the catheter itself looked as if it had been opened and taped closed.She opened another package to see if it was a fluke and it was the same in the second kit as well.

• Brand Name: GROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY)
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6886469
• MDR Text Key: 87880683
• Report Number: 3006260740-2017-01688
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741075230
• UDI-Public: (01)00801741075230
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2017

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: 7715435
• Device Catalogue Number: 7715435
• Device Lot Number: REBN0382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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