MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE; HEYMAN FOLLOWER COMPLETE SET (10-24FR.)

Model Number	021300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 the customer received only a 24fr.When the item should have included 7 additional sizes in the set of 8.Per additional information, it was noted that the packaging did not appear to be for a set of 8.
Additional Manufacturer Narrative
Per additional information received from investigator, bard medical has determined that this mdr was initially reported in error as this event is not reportable.Correction: mfr site.
Event or Problem Description
It was reported that the customer received only a 24fr.When the item should have included 7 additional sizes in the set of 8.Per additional information, it was noted that the packaging did not appear to be for a set of 8.

• Brand Name: BARD HEYMAN FOLLOWERS COUDE TIP, COMPLETE SET 10-24 FR., STERILE
• Common Device Name: HEYMAN FOLLOWER COMPLETE SET (10-24FR.)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7664286
• Report Number: 1018233-2018-02614
• Device Sequence Number: 645834
• Product Code: FBW
• UDI-Device Identifier: 00801741075582
• UDI-Public: (01)00801741075582
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 021300
• Device Catalogue Number: 021300
• Device Lot Number: MCAR3177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1