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

Model Number	319416AM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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.
Event or Problem Description
It was reported that the catheter failed during code blue.No medical intervention was reported.
Additional 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 or Problem Description
It was reported that the catheter failed during code blue.No medical intervention was reported.
Additional 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 or Problem Description
It was reported that the catheter failed during code blue.No medical intervention was reported.

• Brand Name: ALL SILICONE CATHETER
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10223758
• Report Number: 1018233-2020-04226
• Device Sequence Number: 2889881
• Product Code: EZL
• UDI-Device Identifier: 00801741024450
• UDI-Public: (01)00801741024450
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 08/13/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/03/2020; 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1