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

Model Number	154114A
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
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 information provided by bd represents all 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.The device was not returned.
Event or Problem Description
It was reported that the customer received new shipment of urine drainage bags (pcn - 154114a) and would like to compare how the drain bag (pcn - 154114a) was different from the drain bag (pcn - 154004a).Current bag on the patient appeared to have the same drainage spout.Inquirer identified that the current drain bag on patient would have a ceramic insert in it.From what inquirer could see it did not because patient was able to pinch tubing completely and did not feel an insert.Patient had three bags left of 154004a.Drainage bag currently in use was one of those three yet it did not have that insert in it.Customer opened another 154004a package and could feel the insert inside the drainage spout and noted that the bag in use right now, that was supposed to be a 154004a bag, feels exactly like the new bags (154114a).Customer was sure it was supposed to be 154004a with an insert as it was the only bag they used up until it was discontinued and replaced with the bags they received today (154114a).
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 customer received new shipment of urine drainage bags (pcn - 154114a) and would like to compare how the drain bag (pcn - 154114a) was different from the drain bag (pcn - 154004a).Current bag on the patient appeared to have the same drainage spout.Inquirer identified that the current drain bag on patient would have a ceramic insert in it.From what inquirer could see it did not because patient was able to pinch tubing completely and did not feel an insert.Patient had three bags left of 154004a.Drainage bag currently in use was one of those three yet it did not have that insert in it.Customer opened another 154004a package and could feel the insert inside the drainage spout and noted that the bag in use right now, that was supposed to be a 154004a bag, feels exactly like the new bags (154114a).Customer was sure it was supposed to be 154004a with an insert as it was the only bag they used up until it was discontinued and replaced with the bags they received today (154114a).
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be" inspection results (measurement, testing data) not verified by iqa assignee error of inspector ".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.A 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 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 customer received new shipment of urine drainage bags (pcn - 154114a) and would like to compare how the drain bag (pcn - 154114a) was different from the drain bag (pcn - 154004a).Current bag on the patient appeared to have the same drainage spout.Inquirer identified that the current drain bag on patient would have a ceramic insert in it.From what inquirer could see it did not because patient was able to pinch tubing completely and did not feel an insert.Patient had three bags left of 154004a.Drainage bag currently in use was one of those three yet it did not have that insert in it.Customer opened another 154004a package and could feel the insert inside the drainage spout and noted that the bag in use right now, that was supposed to be a 154004a bag, feels exactly like the new bags (154114a).Customer was sure it was supposed to be 154004a with an insert as it was the only bag they used up until it was discontinued and replaced with the bags they received today (154114a).

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: URINARY DRAINAGE BAG
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14653688
• Report Number: 1018233-2022-04522
• Device Sequence Number: 4904936
• Product Code: KNX
• UDI-Device Identifier: 00801741029554
• UDI-Public: (01)00801741029554
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

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 Model Number: 154114A
• Device Catalogue Number: 154004A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 10/10/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/10/2022; 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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