MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SYRINGE

Catalog Number UNKNOWN

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Discomfort (2330)

Event Date 09/18/2020

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 silicone foley had issue with ridges or cuffing at the balloon area, resulting in some discomfort.And had balloon apparently ruptured and slid out without knowing.Patient also noticed the normal flow once the syringe has attached and was never allowed the amount of suggested time of the procedure and instructed to cut the valve off and the syringe had no free movement.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to " plunger grommet not seated properly or no amount of lubricant¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the surgical suction/irrigation product ifus were 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.H3 other text : the device was not returned.

Event Description

It was reported that the silicone foley had issue with ridges or cuffing at the balloon area, resulting in some discomfort.And had balloon apparently ruptured and slid out without knowing.Patient also noticed the normal flow once the syringe has attached and was never allowed the amount of suggested time of the procedure and instructed to cut the valve off and the syringe had no free movement.No medical intervention was reported.

• Brand Name: UNKNOWN SYRINGE
• Type of Device: UNKNOWN SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10689412
• MDR Text Key: 211647785
• Report Number: 1018233-2020-20198
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other