MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POLY MIDLINE (4F) (SINGLE-LUMEN) (MID); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeq3831 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported one of the kits we used on a patient had the introducer damaged or split in half.Patient was not injured during the procedure.We had to open another kit to complete the procedure.

• Brand Name: BARD POLY MIDLINE (4F) (SINGLE-LUMEN) (MID)
• 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: 10279986
• Report Number: 3006260740-2020-02433
• Device Sequence Number: 11473651
• Product Code: LJS
• UDI-Device Identifier: 00801741108051
• UDI-Public: (01)00801741108051
• Combination Product (Y/N): N
• PMA/510(K) Number: K001901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: CK000566
• Device Lot Number: REEQ3831
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1