MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT POWERPICC SOLO; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000169C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 18ab7811 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the triple lumen picc was inserted (b)(6) 2018 at 3:52pm, white lumen broke (b)(6) 2018 at 1am.It was stated this broke without any manipulation to product.Catheter was removed and replaced.
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 connector is confirmed.Multiple broken segments of the proximal section of a white powerpicc solo hub were returned for investigation.One of the segments was attached to an injection valve hub connector.Use residue was observed throughout the returned sample.The cracks were observed to radiate in multiple directions.The main section of the hub appeared to break at the distal end of the injection valve connector with the hub attached.Sections of the broken connector were not returned.Since the hub was broken in multiple fragments, the complaint is confirmed and appears to be manufacturing related.Corrective actions are being implemented at the manufacturing facility.
Event or Problem Description
It was reported the triple lumen picc was inserted 10-16-18 at 3:52pm, white lumen broke 10-17-18 at 1am.It was stated this broke without any manipulation to product.Catheter was removed and replaced.Additional information rec'd via medwatch stated, "white port on tlc picc broke apart within nine (9) hours of placement.".

• Brand Name: DOT POWERPICC SOLO
• 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: 8121367
• Report Number: 3006260740-2018-03457
• Device Sequence Number: 1579114
• Product Code: LJS
• UDI-Device Identifier: 00801741128219
• UDI-Public: (01)00801741128219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019
• Report Date (Section F): 10/26/2018

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: CK000169C
• Device Catalogue Number: CK000169C
• Device Lot Number: 18AB7811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 138
• Date Report Sent to FDA: 10/26/2018