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

Model Number	N/A
Health Effect - Clinical Code	Extravasation (1842)
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebu1284 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the line was found to be leaking and was removed.It was stated that after removed a subcutaneous crack in the tubing was noted which had caused extravasation.
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 is confirmed and was determined to be use related.One 5 fr triple lumen powerpicc provena was returned for evaluation.An initial visual observation showed some use residue and reddish discoloration was observed throughout the majority of the catheter.An approximately 6 mm long, longitudinal split was observed in the catheter between the 2 cm and 3 cm depth markers.The reddish discoloration was less prominent around the area of the split; from the 1 cm to 4 cm depth markers.An attempt was made to flush each lumen of the catheter.A spraying leak was observed emanating from the split when the grey lumen was flushed.The grey lumen was also found to be partially occluded.A microscopic observation revealed the longitudinal split was slightly curved and the edges of the split appeared to be slightly distorted.The fracture surface of the split was observed to be mostly granular in texture, which is typical of tearing failure modes.The location and characteristics of the split observed in the returned catheter, as well as the presence of a partial occlusion, are evidence of a burst failure caused by over-pressurization.The product ifu states: ¿do not infuse against resistance.¿ a lot history review (lhr) of rebu1284 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the line was found to be leaking and was removed.It was stated that after removed a subcutaneous crack in the tubing was noted which had caused extravasation.

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK TIP LOCATION (TLS) SYSTEM
• 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: 7294010
• Report Number: 3006260740-2018-00284
• Device Sequence Number: 16383015
• Product Code: LJS
• UDI-Device Identifier: 00801741112881
• UDI-Public: (01)00801741112881
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: S9385108D
• Device Lot Number: REBU1284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1