MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARDEX 5CC RED LATEX LUBRICATH COUDE TIP (TIEMANN MODEL) 2-WAY FOLEY CATHETER 12

Catalog Number	0102L12
Health Effect - Clinical Code	No Code Available (3191)
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.The device was not returned.
Event or Problem Description
It was reported that the catheter burst.The complainant stated that no pieces were missing, and no medical intervention was required.The complainant also stated that the catheter was removed and replaced without further incident.No patient injury was reported.
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 state the following: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." (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 catheter burst.The complainant stated that no pieces were missing, and no medical intervention was required.The complainant also stated that the catheter was removed and replaced without further incident.No patient injury was reported.

• Brand Name: BARDEX 5CC RED LATEX LUBRICATH COUDE TIP (TIEMANN MODEL) 2-WAY FOLEY CATHETER 12
• Common Device Name: LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• MDR Report Key: 6536585
• Report Number: 1018233-2017-02201
• Device Sequence Number: 81787
• Product Code: EZC
• UDI-Device Identifier: 00801741018107
• UDI-Public: (01)00801741018107
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 0102L12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1