MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT PICC WITH SHERLOCK TIP LOCATION SYSTEM 4F BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 recw1331 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the tls stylet was tested before use and it broke.The device was not used on a patient.
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 stylet break is confirmed but the exact cause is unknown.One 4 fr sl groshong nxt catheter and tls stylet were returned for investigation.The stylet was returned outside of the catheter.A distal segment of the stylet was broken off and measured to be 5.2 cm in length.The section proximal to the break location was kinked and deformed.Microscopic observation revealed the polyimide tubing to be kinked in between magnet location.A section in the main length of the polyimide tubing was compressed with the magnets pushed outwards from the compressed region.The break surfaces appeared to be smooth and slightly oval shaped.The polyimide tubing wall thickness was measured and found to be within manufacturing specification.The event description indicates the tls stylet was tested prior to use which indicates that unintended handling may have been a contributing factor.Since the stylet was observed to be frayed and deformed, the complaint is confirmed.A lot history review (lhr) of recw1331 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the tls stylet was tested before use and it broke.The device was not used on a patient.

• Brand Name: GROSHONG NXT PICC WITH SHERLOCK TIP LOCATION SYSTEM 4F BASIC TRAY (SINGLE-LUMEN)
• 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: 9794032
• Report Number: 3006260740-2020-00766
• Device Sequence Number: 2873853
• Product Code: LJS
• UDI-Device Identifier: 00801741036026
• UDI-Public: (01)00801741036026
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 9655405
• Device Lot Number: RECW1331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1