MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 5F TL TT 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of an eyelash found within a catheter tray was inconclusive due to the nature of the submitted evidence.The product returned for evaluation was one photograph which depicted a portion of 5fr t/l powerpicc catheter tray.The depicted tray was open and several components were visible.The components appeared unused and unremarkable.A portion of label was placed on the folded drape, identifying catalog number ck000741 and lot number recv1202.Also visible on the drape was a curved hair or fiber.While possible eyelash was visible on the drape of the depicted tray, the object could not be conclusively identified through inspection of the submitted photograph.Additionally, the opened state of the tray prevented determination of its original state.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of recv1202 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was an eyelash found within the sterile field of the kit.The device was not used on a patient.

• Brand Name: DOT PPICC 5F TL TT 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: 8299349
• Report Number: 3006260740-2019-00160
• Device Sequence Number: 10779212
• Product Code: LJS
• UDI-Device Identifier: 00801741139673
• UDI-Public: (01)00801741139673
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: CK000741
• Device Lot Number: RECV1202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1