MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUOGLIDE SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13F (DUAL-LUM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 redy1077 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported when one of our intensivists opened the kit to place the line, he found a large strand of hair packaged in the sterile supplies.The kit was not utilized and there was no harm to the patient.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a hair in a kit is inconclusive due to the state of the returned sample.One 13 fr duoglide kit was returned for evaluation.An initial visual observation showed the kit was returned open and the kit components were strewn about the open packaging.No blood residue or other evidence of use was observed on any of the returned components.No hair was found within the kit packaging or on any of the kit components.No hair or other foreign material was found within the returned kit; however, because the kit was returned open, it was not possible to confirm or unconfirm the alleged issue.A lot history review (lhr) of redy1077 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported when one of our intensivists opened the kit to place the line, he found a large strand of hair packaged in the sterile supplies.The kit was not utilized and there was no harm to the patient.

• Brand Name: DUOGLIDE SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13F (DUAL-LUM
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10146024
• Report Number: 3006260740-2020-02078
• Device Sequence Number: 16874897
• Product Code: MPB
• UDI-Device Identifier: 00801741042096
• UDI-Public: (01)00801741042096
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 5625150
• Device Lot Number: REDY1077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1