MAUDE Adverse Event Report: C.R. BARD, INC. (MONCKS) -1030583 BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH

Catalog Number	0165L26
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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 urine would not drain through the catheter.Patient also tried to irrigate the catheter but no liquid was returned.The patient had to deflate the balloon to allow the urine to drain through.He was able to remove the catheter without any issues.The patient allegedly developed a bladder infection shortly after, and had to visit a doctor.He was not prescribed antibiotics.
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: "visually inspect the product for any imperfections or surface deterioration prior to use." (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 urine would not drain through the catheter.The patient also tried to irrigate the catheter ; however, no liquid was returned.The patient had to deflate the balloon to allow the urine to drain successfully.He was able to remove the catheter without any issues.The patient allegedly developed a bladder infection shortly after, and had to visit a doctor.He was not prescribed antibiotics.

• Brand Name: BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH
• Common Device Name: LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (MONCKS) -1030583; 428 power house rd; moncks corner SC 29461
• MDR Report Key: 6536589
• Report Number: 1018233-2017-02197
• Device Sequence Number: 884943
• Product Code: EZC
• UDI-Device Identifier: 00801741017537
• UDI-Public: (01)00801741017537
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0165L26
• 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: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other