MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® MALECOT MODEL DRAIN

Model Number	086030
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that there was foreign material in the package prior to open it.
Additional Manufacturer Narrative
Received 1 unopened urethral catheter.The reported issue was confirmed since foreign loose material was found inside the package.During the visual evaluation, it was noted that loose foreign material was found inside the package that exceeded the specification.The sample was received with the package closed.The reported event was confirmed as manufacturing related.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "indications for use: warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: contains or presence of natural rubber latex warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Sterilized by ethylene oxide do not use if package is damaged.Single use only do not resterilize.Caution, consult accompanying documents." (b)(4).
Event or Problem Description
It was reported that there was foreign material in the package prior to open it.

• Brand Name: BARDEX® MALECOT MODEL DRAIN
• Common Device Name: MALECOT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6957613
• Report Number: 1018233-2017-05328
• Device Sequence Number: 1221767
• Product Code: FEW
• UDI-Device Identifier: 00801741023910
• UDI-Public: (01)00801741023910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

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 Expiration Date: 07/31/2021
• Device Model Number: 086030
• Device Catalogue Number: 086030
• Device Lot Number: NGAY2891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1