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

Model Number	0167V24S
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
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 customer received one cs and instead of 12 ea being in the case there was only 4 ea, and the case was sealed.Per follow up via phone on (b)(6) 2021, customer stated that they only received four catheters instead of a case full.They were in a box that was not taped shut and did not appear as if any tape had been pulled from it.Customer reported the same issue to medline as could not be certain where the problem originated.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the customer received one cs and instead of 12 ea being in the case there was only 4 ea, and the case was sealed.Per follow up via phone on 11jun2021, customer stated that they only received four catheters instead of a case full.They were in a box that was not taped shut and did not appear as if any tape had been pulled from it.Customer reported the same issue to medline as could not be certain where the problem originated.

• Brand Name: BARDEX FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12099745
• Report Number: 1018233-2021-03925
• Device Sequence Number: 4700840
• Product Code: KOD
• UDI-Device Identifier: 00801741019241
• UDI-Public: (01)00801741019241
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: Lay User/Patient
• Device Model Number: 0167V24S
• Device Catalogue Number: 0167V24S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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