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

Model Number 319416AM

Device Problems Material Fragmentation (1261); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 catheter failed during code blue.No medical intervention was reported.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d1, d4.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.

Event Description

It was reported that the catheter failed during code blue.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted 3 photo samples were received showing the packaging and foley catheter.Visual evaluation noted that the catheter was broken in half about halfway down the catheter's shaft.This failed to meet specifications per the standard which states no holes, rips, or cracks in components are allowed.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be incorrect material formulation.The lot number is unknown therefore the device history record could not be reviewed.The product family for this silicone foley catheter product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product family is unknown, the silicone foley catheter ifus are found to be adequate based on past reviews.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.

Event Description

It was reported that the catheter failed during code blue.No medical intervention was reported.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10223758
• MDR Text Key: 197852426
• Report Number: 1018233-2020-04226
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741024450
• UDI-Public: (01)00801741024450
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

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 Model Number: 319416AM
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 06/11/2020; 08/13/2020
• Supplement Dates FDA Received: 07/03/2020; 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1