MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 3F MAXIMAL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebw1997 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the device was inserted on (b)(6) 2018.It was stated at approximately 6pm the next day, during a contrast injection for a ct scan, the device ruptured.According to the radiology documentation indicated that the rate on the injector was sent for 1 ml/second.The catheter was reported to have flushed easily and had blood return prior to the power injection.Catheter had been used for intermittent infusion of ampicillin and cefapime.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter was confirmed, and determined to be use related.One 3fr s/l powerpicc sv was returned for investigation.The returned sample revealed evidence of use.Blood residue was visible within the distal end of the catheter.The catheter extended 37.5cm from the distal end of the molded wing.A longitudinal split was observed in the s/l catheter tubing near the 5cm mark.The split coincided with a kink in the tubing.A microscopic examination of the split revealed a rough and granular edge and adjoining surfaces.A tactual investigation revealed that the tubing had the tendency to kink across the split that was found in the tubing.The split and kink observed in the catheter indicates that the tubing was placed in a location that was susceptible to kinking.The repeated kinking of the catheter most likely stressed the tubing to the point where the catheter material began to split.The product ifu indicates to avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.A lot history review (lhr) of rebw1997 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the device was inserted on (b)(6) 2018.It was stated at approximately 6pm the next day, during a contrast injection for a ct scan, the device ruptured.According to the radiology documentation indicated that the rate on the injector was sent for 1 ml/second.The catheter was reported to have flushed easily and had blood return prior to the power injection.Catheter had been used for intermittent infusion of ampicillin and cefapime.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 3F MAXIMAL
• 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: 7309620
• Report Number: 3006260740-2018-00328
• Device Sequence Number: 2301057
• Product Code: LJS
• UDI-Device Identifier: 00801741035531
• UDI-Public: (01)00801741035531
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• 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): 04/30/2018

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: 9173108D
• Device Lot Number: REBW1997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 DA