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	06/09/2020
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 redw1120 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that leakage was found during infusion.There was no reported patient injury.
Event or Problem Description
It was reported that leakage was found during 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, 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 leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 5fr d/l groshong catheter.Use residues were observed throughout the sample and needleless injection caps were attached to both luers.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization of the sample.Microscopic inspection of the sample did not reveal any evidence of damage or leakage.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.A lot history review (lhr) of redw1120 showed no other similar product complaint(s) from this lot number.

• 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: 10434553
• Report Number: 3006260740-2020-02990
• Device Sequence Number: 11567819
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: REDW1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1