MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9295108D
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
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 reported incident of a knot in the guidewire was confirmed, but the exact cause of the complaint is unknown.The guidewire was received with an overhand knot in the coiled end of the wire.The distal tip of the wire extended 5.5mm from the knot.A 3mm segment of dislocations in adjoining coils was noted 5mm proximal to the knot, which is most likely associated with the tension in the coils due to the knot.A microscopic examination of the guidewire revealed residue on the coil wire at the knot.A tactual investigation revealed that the coil wire was intact over the core wire.It was reported that the.It is possible that the wire inadvertently folded over itself and was twisted into a knot within the vein.No manufacturing related defects were noted on the complaint sample.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rezj0720 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - it was reported by complainant, that the stylet was stuck in the picc during placement and the patient had to be referred to another facility for picc removal.The patient was not harmed.The other facility did not retain or will not release the removed picc/stylet.On (b)(6) 2016 - as reported by complainant, they were able to obtain the stylet and have a cd of the x-ray.On (b)(6) 2016 - as reported, the other facility that the patient was sent to have the picc removed was ir.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI
• 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: 5564439
• Report Number: 3006260740-2016-00160
• Device Sequence Number: 424200
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760(17)170331(10)REZJ0720
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 9295108D
• Device Lot Number: REZJ0720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2016
• Initial Report FDA Received Date: 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1