MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F MAXIMAL BARRIER TRAY W; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1396108D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recr0547 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by a rn at the hospital that the picc was placed on (b)(6) 2018.It was stated that the picc was fully functional without problems.The rn was called to assess this same picc on (b)(6) 2018.It was noted that it was leaking when the white lumen was flushed.The picc was exchanged.
Event or Problem Description
It was reported by a rn at the hospital that the picc was placed on (b)(6)2018.It was stated that the picc wasfully functional without problems.The rn was called to assess this same picc on (b)(6)2018.It was noted that it was leaking when the white lumen was flushed.The picc was exchanged.
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 most-likely related to use.One 6 fr triple lumen powerpicc solo was returned for evaluation.An initial visual observation showed use residue on the returned sample and the extension legs were discolored.All three lumens were flushed and pressurized with a 12ml syringe of water.A spraying leak was observed emanating near the 1 cm depth marker when the grey lumen was pressurized.A microscopic observation revealed a small longitudinal split in the catheter approximately 1.8 cm distal to the molded joint.The split was observed to be straight and even and the fracture surface was observed to be flat and granular in texture.A circumferential crease was noticed on the surface of the catheter, perpendicular to the split, and some discoloration was observed in the catheter material near the split.During manipulation of the catheter, it was observed that the catheter kinked easily at the site of the split and about 0.5 cm distal to the split.The characteristics of the split in the returned catheter 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.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The product ifu states: ¿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 recr0547 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F MAXIMAL BARRIER TRAY W
• 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: 8028465
• Report Number: 3006260740-2018-03066
• Device Sequence Number: 1303309
• Product Code: LJS
• UDI-Device Identifier: 00801741034749
• UDI-Public: (01)00801741034749
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 1396108D
• Device Catalogue Number: 1396108D
• Device Lot Number: RECR0547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1