MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DILATION PRODUCTS

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that the survey respondent stated no, the instructions for use (ifu) for the eagle inflation device did not provide sufficient information about the product and its medical application because did not get adequate information on this.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Section a through f - the information provided by bd represents all 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.The device was not returned.

Manufacturer Narrative

The reported event is inconclusive as no sample was provided for evaluation.Although an exact root cause could not be determined a potential root cause could be user unaware of conditions that will increase risk of using device and performing procedure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Labelling review is not required as the product catalog number is unknown.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that in an online survey the physician stated no, the instructions for use (ifu) for the eagle inflation device did not provide sufficient information about the product and its medical application because did not get adequate information on this.

• Brand Name: DILATION PRODUCTS
• Type of Device: DILATION PRODUCTS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17009740
• MDR Text Key: 316005978
• Report Number: 1018233-2023-03791
• Device Sequence Number: 1
• Product Code: FBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other