MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SHERLOCK 3CG BARD MYPICC KIT 4F (SINGLE-LUMEN) (TIP POSITIONING SYSTEM; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/23/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 16yb4307 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the picc was removed from the package and the healthcare professional noted that the picc had a visible bubble from the preloaded stylet.Device was not used on the patient and was set on the side table.When setting the device on the table it "broke".
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 break in the stylet was confirmed, but based on the evidence that was provided for investigation, the exact cause could not be determined.One photograph, showing what appears to be a stylet wire, was provided for investigation.The wire was shown in two segments.It appears that the stylet contained a magnetic tip and the break was located in the magnetic section of the stylet.The proximal segment of the magnetic tip was kinked.The section of stylet proximal to the magnets was curled.Kinking and curling the magnetic tip of the stylet wire may lead to stylet damage; however, the exact cause could not be determined from the photograph.
Event or Problem Description
Facility reported to the sales rep that the picc was removed from the package and the healthcare professional noted that the picc had a visible bubble from the preloaded stylet.Device was not used on the patient and was set on the side table.When setting the device on the table it "broke".

• Brand Name: POWERPICC SHERLOCK 3CG BARD MYPICC KIT 4F (SINGLE-LUMEN) (TIP POSITIONING SYSTEM
• 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: 6726334
• Report Number: 3006260740-2017-01095
• Device Sequence Number: 822240
• Product Code: LJS
• UDI-Device Identifier: 00801741042607
• UDI-Public: (01)00801741042607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: CK000130
• Device Lot Number: 16YB4307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1