MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lot history review (lhr) of reaz0588 showed no other similar product complaint(s) from this lot number.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.
Event or Problem Description
It was reported that patient used a picc device (bard groshong 3fr).It was noticed that the dressing was wet, when opening it was identified that the silicone catheter was separated from the connector.It was decided to perform the repair by changing the connector.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8946208
• Report Number: 3006260740-2019-02522
• Device Sequence Number: 14105784
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: N/A
• Device Catalogue Number: 7755305
• Device Lot Number: REAZ0588
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1