MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) ST; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recz2080 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during taxol chemo treatment, infusion staff noted liquid dripping from the entry point, upon flushing liquid was noted from around 4cm above the insertion site.No other information 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 catheter leak was confirmed and appears to be related to the use of the device.The product returned for evaluation was one 4 fr groshong nxt catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed near the 41 cm depth marker.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing) an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of recz2080 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during taxol chemo treatment, infusion staff noted liquid dripping from the entry point, upon flushing liquid was noted from around 4cm above the insertion site.No other information provided.

• Brand Name: GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) ST
• 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: 9276007
• Report Number: 3006260740-2019-03447
• Device Sequence Number: 13498008
• Product Code: LJS
• UDI-Device Identifier: 00801741028687
• UDI-Public: (01)00801741028687
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 801(E)
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: CK000516
• Device Lot Number: RECZ2080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1