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

Model Number	7715435
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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)
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6886469
• Report Number: 3006260740-2017-01688
• Device Sequence Number: 13577251
• Product Code: DQY
• UDI-Device Identifier: 00801741075230
• UDI-Public: (01)00801741075230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K871080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 7715435
• Device Catalogue Number: 7715435
• Device Lot Number: REBN0382
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1