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

Catalog Number	7715435
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2016
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 for evaluation.A lot history review (lhr) of rezk0988 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
(b)(4) it was reported that a patient with lung cancer and a tracheostomy tube was being mechanically ventilated and was hospitalized for acute respiratory failure.A groshong midline catheter was placed via the basilic vein of right arm with ultrasound on (b)(6) 2016.The catheter was placed for blood sampling and intravenous therapy infusions.The catheter was reportedly placed without difficulty or complications with 1.5 cm of the catheter left outside the body.The device was stabilized with a transparent dressing film instead of a statlock.It was stated that the device was treated and controlled in accordance to hospital procedure.On (b)(6), at 4 am, the patient was highly agitated and was taken off the tracheostomy tube and the midline catheter.The nurse found that at the insertion site on the patient's skin that the gray and purple device, with the luer-lock, had reportedly been detached from the blue cone of the catheter.It was said that the blue cone had been torn from the gray portion, leaving only the connector blunt attaching the two pieces together.The catheter was removed to avoid migration in the venous circulation.

• Brand Name: GROSHONG MID LINE MINI TRAY 4F
• 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: 5632236
• Report Number: 3006260740-2016-00206
• Device Sequence Number: 10875561
• Product Code: DQY
• UDI-Device Identifier: 00801741075230
• UDI-Public: (01)00801741075230(17)201028(10)REZK0988
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K871080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/12/2016

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 Expiration Date: 10/28/2020
• Device Catalogue Number: 7715435
• Device Lot Number: REZK0988
• 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: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR