MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redv2858 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the groshong picc broke.The rn stated, "i went to change the patient¿s dressing and the pieces were already disconnected." no other information was provided.
Event or Problem Description
It was reported the groshong picc broke.The rn stated, "i went to change the patient¿s dressing and the pieces were already disconnected." no other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged strain relief oversleeve was confirmed, but the exact cause could not be determined from the two photographs that were provided for investigation.One photo showed the label with part number 9617408d and lot #redv2858.The other photo showed a groshong nxt picc at the insertion site.The wings were attached to a statlock stabilization device.There was a complete circumferential break in the strain relief oversleeve at the distal end of the connector.The detached strain relief oversleeve remained attached around the catheter but the distal tip was positioned at the insertion site.The catheter appeared to be secured to the connector.No defects associated with the manufacturing process were identified on the oversleeve.What appeared to be tape residue was observed on the distal connector.It is possible that the break in the oversleeve was attributable to tensile stress or fatigue; however, the cause could not be determined from the photographs.A lot history review (lhr) of redv2858 showed no other similar product complaint(s) from this lot number.

• Brand Name: GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F
• 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: 9982842
• Report Number: 3006260740-2020-01449
• Device Sequence Number: 2953167
• Product Code: LJS
• UDI-Device Identifier: 00801741036019
• UDI-Public: (01)00801741036019
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 9617408D
• Device Lot Number: REDV2858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 186