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	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
During device evaluation, it was determined that there was a material "flaw" on the catheter shaft.
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), applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a material flaw is confirmed and was determined to be supplier related.One 5 fr dual lumen groshong nxt catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.A microscopic observation revealed what appears to be excess silicone material on the outer surface of the catheter between the 25 cm and 26 cm depth markers.This excess silicone material appeared to be completely connected to the catheter shaft.The catheter was cut at the location of the excess silicone and the outer diameter of the catheter was found to be too large and out of specification at this location.The piece of excess silicone was found to be completely connected to the catheter; however, a line could be seen between the excess material and the material of the catheter.The cross-section of the catheter was observed to be slightly elliptical.The investigation has been forwarded to the manufacturing facility for further evaluation.Reynosa evaluation complaint due to ¿material "flaw" on the catheter shaft¿ was confirmed.According with the photo evaluation performed at reynosa facility and vad field assurance evaluation the following was concluded: the amount of silicone excess that was found to be adhered on the catheter shaft it was caused during the extrusion process of the blue tubing.Therefore, the cause of this condition is supplier related.An incident report was issued to notify our supplier about this issue.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
During device evaluation, it was determined that there was a material "flaw" on the catheter shaft.

• 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: 9701596
• Report Number: 3006260740-2020-00500
• Device Sequence Number: 11368412
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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 Model Number: N/A
• Device Catalogue Number: 7927505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1