MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER, 4 F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hair found in device packaging was inconclusive due to the nature of the returned sample.The product returned for evaluation was one piece of cardstock with attached product labeling.The product labeling tag identified catalog number ck000687 and corporate lot number recx2670.A hair-like fiber was attached to the cardstock with a piece of medical tape.Microscopic inspection of the sample confirmed that the fiber appeared consistent with a hair.Inspection of the returned sample did not inform the original state of the implicated catheter tray.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of recx2670 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a hair was found on the chloraprep stick in sterile custom kit.Device was not used on patient.

• Brand Name: POWERPICC SOLO CATHETER, 4 F SL, 3CG
• 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: 8777742
• Report Number: 3006260740-2019-01903
• Device Sequence Number: 1832697
• Product Code: LJS
• UDI-Device Identifier: 00801741136535
• UDI-Public: (01)00801741136535
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/10/2019

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: N/A
• Device Catalogue Number: CK000687
• Device Lot Number: RECX2670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1