MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER, &; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
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 damaged 3cg stylet was inconclusive because no sample was returned for evaluation.Based on the description of the reported event, possible contributing factors include tensile (pulling) stress, attempted insertion against resistance and inserting the stylet past the tip of the catheter; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.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 rect2165 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported that during placement the tip of the 3cg wire broke off inside the patient.Ir detected it under fluro.Patient transferred to vascular surgeon for removal of 3cg stylet tip.Additional information received from ms&s stated, "from [territory manager's] description of the event it sounded like the inserter hit an obstruction and kept trying to push the picc through the obstruction and then had difficulty removing the picc." additional information stated, "the stylet fragment was removed." on (b)(6) 2018 per medwatch: the patient presented for placement of a picc.Nursing staff reported that during the insertion process, they discovered that a portion of the wire had broken off and remained in the patient.After consultation with radiologist and patient's physician, the decision was made to transfer patient to hospital to have the broken piece of the wire removed.

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER, &
• 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: 8077767
• Report Number: 3006260740-2018-03242
• Device Sequence Number: 14033925
• Product Code: LJS
• UDI-Device Identifier: 00801741155215
• UDI-Public: (01)00801741155215
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2018
• Report Date (Section F): 10/29/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: S1295108FD5
• Device Lot Number: RECT2165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Date Report Sent to FDA: 10/29/2018