MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SYRINGE IRRIGATION BULK / CLEAN, 50ML; IRRIGATION SYRINGE

Model Number	0935280
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/21/2021
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 there was moisture in the bulb syringe.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The reported failure is considered within specification as the reported failure could not be reproduced.The product was not used for patient treatment.The reported failure is considered within specification as the reported failure could not be reproduced.No root cause could be found because the reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (without original packaging), 1 used irrigation syringe bulb.Visual inspection of the sample noted no moisture or damage found on the return sample.The device was returned for evaluation.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.As the reported event is unconfirmed a risk review and labeling review is not required.The actual/suspected device was inspected.
Event or Problem Description
It was reported that there was moisture in the bulb syringe.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Common Device Name: IRRIGATION SYRINGE
• 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: 12174100
• Report Number: 1018233-2021-04235
• Device Sequence Number: 1632419
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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 Expiration Date: 11/30/2025
• Device Model Number: 0935280
• Device Catalogue Number: 0935280
• Device Lot Number: NGEY0583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown