MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redn2197 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient had a groshong catheter implanted on (b)(6) 2020.Leakage was found at the part of the catheter out side of the patient when flushing on the following day.It was further reported that another rumen has been used for infusion.There was no reported patient injury.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed but the exact cause remains unknown.One 5 fr dl groshong catheter was returned for evaluation.A statlock securement device was attached to the suture wing.A second suture wing was attached to the catheter.The lumens were flushed with water using a 12 ml syringe and a leak was observed when flushing through the red hub.The leak was located in the catheter length between the two suture wings.Microscopic observation of the leak location revealed a small circumferential split which appears to have two propagating longitudinal splits.The split had an oval shape when the catheter was manipulated to observe the inner surface.The shape of the leak location suggests a sharp instrument may have contributed to the damage observed.The catheter was cut near the leak location in order to measure the catheter dimensions.The wall thickness was found to be within manufacturing specification.Since a leak was observed on the returned sample the complaint is confirmed but the exact cause of the damage remains unknown.Based on the condition of the sample returned, possible contributing factors include sharp instrument damage and damage during handling.A lot history review (lhr) of redn2197 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patient had a groshong catheter implanted on (b)(6) 2020.Leakage was found at the part of the catheter out side of the patient when flushing on the following day.It was further reported that another rumen has been used for infusion.There was no reported patient injury.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER
• 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: 10314954
• Report Number: 3006260740-2020-02671
• Device Sequence Number: 17007152
• Product Code: LJS
• UDI-Device Identifier: 00801741035401
• UDI-Public: (01)00801741035401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 7927505
• Device Lot Number: REDN2197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1