MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2017
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 to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaz1272 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that after insertion it was noticed that there was a fracture at the end of the white lumen.The lumen was stated to be unusable as fluid was leaking from fracture.The patient was critically ill with limited iv access.No patient injury was reported.
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 broken solo connector is confirmed, and the cause is determined to be likely manufacturing related.The device returned was one triple lumen powerpicc solo.Visual observation found blood residue at the distal end and what may be adhesive on the extension legs, potentially from an adhesive dressing.There appeared to be a missing piece of material on the proximal end of the white connector, and a crack appeared to extend from near this point distally down the white portion of the connector.Visual observation found blood residue at the distal end and what may be adhesive on the extension legs, potentially from an adhesive dressing.There appeared to be a missing piece of material on the proximal end of the white connector, and a crack appeared to extend from near this point distally down the white portion of the connector.This damage appears to due to brittle failure.Functional testing found a leak in the white connector during infusion, but not in the gray or red connectors.No other leaks were found.Microscopic evaluation found the chip and crack to be separate, but close, and the chip was concave.The crack was actually formed from two cracks very near to each other.The distal end of the catheter appeared very smooth, with sharp edges, indicating a probable intentional trim.The appearance of the catheter fracture indicates a probable material and/or molding issue, a manufacturing-related root cause.The device will therefore be forwarded to the manufacturing facility for further evaluation.An rap has been initiated for this type of failure, and it is known that the lot was created before the creation of any related capa.(b)(4) evaluation the complaint for ¿valve cracked¿ is confirmed according the evaluation the sample received which showed a microscopic evaluation showed an break in the molding valve , maybe those are caused by the incorrect molding process, leading to valve breakage., maybe these are caused by the incorrect molding process, leading to valve breakage.This condition cause leak in the device.Therefore the cause for this complaint is manufacturing related.An event was opened for the tracking of this issue.A lot history review (lhr) of reaz1272 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after insertion it was noticed that there was a fracture at the end of the white lumen.The lumen was stated to be unusable as fluid was leaking from fracture.The patient was critically ill with limited iv access.No patient injury was reported.

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F
• 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: 6726301
• Report Number: 3006260740-2017-01093
• Device Sequence Number: 19037914
• Product Code: LJS
• UDI-Device Identifier: 00801741035913
• UDI-Public: (01)00801741035913
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 9395118Q
• Device Lot Number: REAZ1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1