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

Catalog Number 33428

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that there was a hair inside the closed packaging of the foley catheter.

Event Description

It was reported that there was a hair inside the closed packaging of the foley catheter.

Manufacturer Narrative

The reported event was confirmed manufacturing related.The device had not met specifications.Visual evaluation of the returned sample noted one unopened (with original packaging), silastic foley catheter.Visual inspection of the sample noted no visible nonconformities.A strand of hair was observed inside the unopen package.This does not meet specification which states that " loosen hair in package and/or trapped in sealing is not allowed".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labelling could not have prevented the reported failure.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 actual/suspected device was inspected.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• 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: 17379175
• MDR Text Key: 319676189
• Report Number: 1018233-2023-05409
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020049
• UDI-Public: (01)00801741020049
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 33428
• Device Lot Number: NGGU3808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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