MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE; IRRI TRAY PISTN SYRINGE

Catalog Number	750307
Health Effect - Clinical Code	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 irrigation syringes were not holding a seal, so when trying to draw up volume to irrigate, irrigation fluid just poured back out.Health professionals were not able to fill the syringe, which was necessary to effectively irrigate a bladder.Four different irrigation syringes were tried, all with the same result and all with the same lot number.Per complainant statement, it significantly affected patient care over approximately 20 hours.Night shift was unable to properly irrigate the clots, which required a foley catheter replacement.The patient was scheduled for surgery the next morning.After surgery, day shift was unable to properly irrigate the foley when it became clotted again, so it was again exchanged.
Additional Manufacturer Narrative
Upon further review, bard/bd has determined that this mdr was reported in error as this event is not reportable.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 irrigation syringes were not holding a seal, so when trying to draw up volume to irrigate, irrigation fluid just poured back out.Health professionals were not able to fill the syringe, which was necessary to effectively irrigate a bladder.Four different irrigation syringes were tried, all with the same result and all with the same lot number.Per complainant statement, it significantly affected patient care over approximately 20 hours.Night shift was unable to properly irrigate the clots, which required a foley catheter replacement.The patient was scheduled for surgery the next morning.After surgery, day shift was unable to properly irrigate the foley when it became clotted again, so it was again exchanged.

• Brand Name: BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE
• Common Device Name: IRRI TRAY PISTN SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9916488
• Report Number: 1018233-2020-02290
• Device Sequence Number: 3329408
• Product Code: KYZ
• UDI-Device Identifier: 00801741051111
• UDI-Public: (01)00801741051111
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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 Catalogue Number: 750307
• Device Lot Number: NGDY1955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1