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

Model Number	150832
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the extension tubing in the leg bag was missing from the package.Customer had to use the extension tube from another package to utilize first bag.Per additional information received via sample form on 25jan2023, it was stated that the leg bag did not have the connecting tube.Per follow-up via phone on 25jan2023, it was reported that once they purchased this product from the local pharmacy, it was missing a piece.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was inconclusive since sample condition was poor.It was unknown whether the device had met relevant specifications.The product was not used for patient treatment.A potential root cause for this failure mode could be ¿defective components received from supplier".Visual evaluation of the returned sample noted one opened (with original packaging), dispoz-a-bag.Visual inspection of the sample noted that the packaging was empty, and no sample was return for evaluation, therefore this investigation is considered inconclusive.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: "directions for use: separate notches within circles.Pull straps through holes and around leg.Position bag on leg with flutter valve at top.Attach catheter or extension tubing to top inlet.When wearing bag below knee, attach bard® extension tubing (catalog no.150615 or 4a4194).When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector.To empty dispoz-a-bag®, push green lever on flip-flo¿ valve out and down.Important: be sure to reclose flip-flo¿ valve after emptying bag.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable, local, state and federal laws and regulations." 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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the extension tubing in the leg bag was missing from the package.Customer had to use the extension tube from another package to utilize first bag.As per additional information received via sample form on 25jan2023, it was stated that the leg bag did not have the connecting tube.As per follow-up via phone on 25jan2023, it was reported that once they purchased this product from the local pharmacy, it was missing a piece.

• Brand Name: LEG BAG
• Common Device Name: LEG 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16282987
• Report Number: 1018233-2023-00546
• Device Sequence Number: 12458885
• Product Code: FAQ
• UDI-Device Identifier: 00801741050886
• UDI-Public: (01)00801741050886
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Model Number: 150832
• Device Catalogue Number: 150832
• Device Lot Number: NGGT3587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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