MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PEEL-APART INTRODUCER KIT,15F; PORT AND CATHETER ACCESSORIES

Model Number	0601115
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation.Therefore, the investigation is inconclusive for the reported component missing issue.The definitive root cause could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates the model 0601115 port and catheter accessories allegedly experienced component missing.The report was received from a single source.This malfunction did not involve a patient as there was no patient contact.The patient's age, gender and weight was not provided.

• Brand Name: PEEL-APART INTRODUCER KIT,15F
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10737831
• Report Number: 3006260740-2020-03476
• Device Sequence Number: 1114803
• Product Code: DYB
• UDI-Device Identifier: 00801741038297
• UDI-Public: (01)00801741038297
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: No Information
• Device Model Number: 0601115
• Device Catalogue Number: 0601115
• Device Lot Number: REDQ0398
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1