MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC® HF CATHETER WIT H BASIC KIT AND RADSTIC® MICROINTRODUCER; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	3385355Q
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 5fr t/l powerpicc catheter.Usage residues were observed throughout the sample.The catheter was received in two segments which shared a complete break between the 15cm and 16cm depth markings.Microscopic inspection of both the ends of the complete break and the distal end of the sample revealed striations typical of sharp instrument cuts.Abundant mechanical damage was seen between the molded joint and the 8cm depth marking comprising kinks, compressed regions, material deformation, material discoloration and depth marking wear.A longitudinally aligned split was observed at the 3cm depth marking.A partially fractured fragment of web wall protruded from the split.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a spraying leak was observed emanating from the site of the aforementioned split.Tactile inspection of the sample revealed tensile weakness throughout the damaged region.Microscopic inspection of the split revealed sharply defined granular edges.The fracture edges exhibited a granular texture.The split occurred within a region of longitudinally aligned catheter tube compression.Longitudinally aligned catheter buckling was visible in the vicinity of the split.The abundant damage between the molded joint and the 8cm depth marking appeared to be the result of excessive manipulation/compression of the catheter tubing.The split itself was likely caused by compression of the catheter and may have been the result of catheter securement.Care should be taken when securing, accessing and maintaining catheters to avoid causing damage.A lot history review (lhr) of rezl1762 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 05/12/2016- per sales representative user facility reported that after a picc was placed they were unable to draw blood and had difficulty flushing.It was said that they checked for a mechanical obstruction, flushed the picc and then noticed saline leaking from insertion site.The picc was further retracted, flushed twice and reportedly a puncture was noted.The picc was removed.

• Brand Name: POWERPICC® HF CATHETER WIT H BASIC KIT AND RADSTIC® MICROINTRODUCER
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5693058
• Report Number: 3006260740-2016-00242
• Device Sequence Number: 16370281
• Product Code: LJS
• UDI-Device Identifier: 00801741028205
• UDI-Public: (01)00801741028205(17)180928(10)REZL1762
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/11/2016

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: 09/28/2018
• Device Catalogue Number: 3385355Q
• Device Lot Number: REZL1762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2016
• Initial Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1