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	05/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reds3592 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that chemotherapy was started by placing the groshon catheter on (b)(6) 2020.The leakage was found near the suture wing and there was a crack at connection part of the catheter, during blinatumomab infusion on (b)(6) 2020.It was further reported that there was no external force on this connection part.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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter was inconclusive due to the nature of the returned sample.The product returned for evaluation was one photograph depicting a 5fr d/l groshong catheter.The depicted portion of the catheter included the molded joint, which was placed in a statlock stabilization device and a portion of catheter shaft.A circle was inscribed around the molded joint with text indicating ¿crack on this part.¿ no crack was discernible in the submitted photograph.While no crack was discernible in the photograph, the device could not be thoroughly evaluated.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of reds3592 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that chemotherapy was started by placing the groshon catheter on (b)(6) 2020.The leakage was found near the suture wing and there was a crack at connection part of the catheter, during blinatumomab infusion on (b)(6) 2020.(please refer to the attached picture) it was futher reported that there was no external force on this coneection part.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: 10195828
• Report Number: 3006260740-2020-02235
• Device Sequence Number: 13690755
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 7927505
• Device Lot Number: REDS3592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1