MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER

Model Number	154003
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/17/2020
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.
Event or Problem Description
It was reported that the catheter balloon was difficult to deflate and remove.8 ml was removed and no further fluid could be removed.The catheter appeared to be suctioning in on itself.As the tubing was being pulled from the patient, some mild resistance was met.Another attempt to remove fluid was unsuccessful.The patient complained of discomfort as the catheter was pulled out.Once removed, it was noted that the balloon was still inflated to approximately the size of a marble.The remaining fluid/air in the balloon could not be removed.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.Potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).The lot number was unknown; therefore, the device history record could not be reviewed.Unable to review the labelling due to unknown product code.Although the product family was unknown, the foley catheter ifus were found to be adequate based on past reviews.H11:section a through f - 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.
Event or Problem Description
It was reported that the catheter balloon was difficult to deflate and remove.8 ml was removed and no further fluid could be removed.The catheter appeared to be suctioning in on itself.As the tubing was being pulled from the patient, some mild resistance was met.Another attempt to remove fluid was unsuccessful.The patient complained of discomfort as the catheter was pulled out.Once removed, it was noted that the balloon was still inflated to approximately the size of a marble.The remaining fluid/air in the balloon could not be removed.

• Brand Name: LATEX FOLEY CATHETER
• Common Device Name: LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10992693
• Report Number: 1018233-2020-21592
• Device Sequence Number: 17034756
• Product Code: EZC
• UDI-Device Identifier: 00801741040771
• UDI-Public: (01)00801741040771
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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 Model Number: 154003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 05/19/2021
• 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
• Patient Age: 73 YR
• Patient Weight: 100