MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CLOSED SYSTEM URINARY DRAINAGE BAG

Model Number	N153504
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
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.The device was not returned.
Event or Problem Description
It was reported that the patient arrived to post anesthesia care unit (pacu) from operating room after hernia repair surgery in which patient received 3 liters of iv fluid.A foley urinary catheter was placed in the operating room.Upon arrival to the post anesthesia care unit (pacu), the surgeon noticed the foley was not draining urine.On closer inspection, it was discovered the foley tubing had a manufacture defect and was occluded by a piece of plastic preventing urine from draining into foley bag.Per additional information received via email on 14oct2020 from the complainant, the foley catheter itself was functioning.The tubing to the bag itself had some kind of blockage.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "not follow inspection procedure".The lot number was unknown.Therefore, the device history record could not be reviewed.Labeling review was not performed, because labeling could not have prevented the reported failure.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 or Problem Description
It was reported, that the patient arrived to post anesthesia care unit (pacu).From operating room, after hernia repair surgery.In which, patient received 3 liters of iv fluid.A foley urinary catheter was placed in the operating room.Upon arrival to the post anesthesia care unit (pacu), the surgeon noticed, the foley was not draining urine.On closer inspection, it was discovered, the foley tubing had a manufacture defect.And was occluded by a piece of plastic preventing urine from draining into foley bag.Per additional information received via email on (b)(6) 2020 from the complainant, the foley catheter itself was functioning.The tubing to the bag itself had some kind of blockage.

• Brand Name: BARD CLOSED SYSTEM URINARY DRAINAGE BAG
• Common Device Name: URINARY DRAINAGE BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10681978
• Report Number: 1018233-2020-20153
• Device Sequence Number: 16286481
• Product Code: KNX
• UDI-Device Identifier: 10801741046763
• UDI-Public: (01)10801741046763
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: N153504
• Device Catalogue Number: N153504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR