MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,4FR POWERMIDLINE; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redq0755 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "regarding the peel away sheet in the kit, when they broke it and went to peel it away, it broke away from the handle and they had to use forceps to remove it from the patient." additional information received: "placed in patient when sheath was cracked and peeled, one side of the sheath became detached from the handle.Needed to be removed with forcep.".

• Brand Name: DOT,4FR POWERMIDLINE
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9768705
• Report Number: 3006260740-2020-00662
• Device Sequence Number: 11229272
• Product Code: PND
• UDI-Device Identifier: 00801741108754
• UDI-Public: (01)00801741108754
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: P4154108
• Device Lot Number: REDQ0755
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1