MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL NG PREP 200BX; STATLOCK

Catalog Number	NG0120
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "sterile only when included as a component in a sterile kit.This package does not maintain sterility; use once catheter kit package is opened.Discard if package is opened or damaged.1.Peel off backing.2.Adhere to nose.3.Wrap around tube.4.Change every 3-5 days." (b)(4).The information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the statlock nasogastric peeled off despite using skin protectant.

• Brand Name: SL NG PREP 200BX
• Common Device Name: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6958149
• Report Number: 1018233-2017-05345
• Device Sequence Number: 13633066
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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 Catalogue Number: NG0120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1