MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)

Catalog Number 1758SI12

Device Problems Unsealed Device Packaging (1444); Shipping Damage or Problem (1570); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported that the foley catheter boxes were not sealed properly in which end flaps were torn off and exposed to the element.

Manufacturer Narrative

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

Event Description

It was reported that the foley catheter boxes were not sealed properly in which end flaps were torn off and exposed to the element.Per follow up on 09feb2022, customer stated that the actual boxes that the catheters were in, not an outer shipping box, was never fully sealed.The catheters they received from care providers were not shipped in a shipping box and were left on their porch in only the foley box and that the boxes were just closed with a small piece of tape that was not secure.Customer would like for the foley boxes to be sealed completely.

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.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.

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 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.H3 other text : the device was not returned.

Event Description

It was reported that the foley catheter boxes were not sealed properly in which end flaps were torn off and exposed to the element.Per follow up on 09feb2022, customer stated that the actual boxes that the catheters were in, not an outer shipping box, was never fully sealed.The catheters they received from care providers were not shipped in a shipping box and were left on their porch in only the foley box and that the boxes were just closed with a small piece of tape that was not secure.Customer would like for the foley boxes to be sealed completely.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.The device was not returned.

Event Description

It was reported that the foley catheter boxes were not sealed properly in which end flaps were torn off and exposed to the element.Per follow up on 09feb2022, customer stated that the actual boxes that the catheters were in, not an outer shipping box, was never fully sealed.The catheters they received from care providers were not shipped in a shipping box and were left on their porch in only the foley box and that the boxes were just closed with a small piece of tape that was not secure.Customer would like for the foley boxes to be sealed completely.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13497683
• MDR Text Key: 285460387
• Report Number: 1018233-2022-00490
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1758SI12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• 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