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

Model Number	0015850
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2018
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 print on the bile bag appeared to have been assembled upside down.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related, since this part assembly occurred during manufacturing.Visual evaluation of the returned sample noted one opened (without original packaging), bile bag.The bag appeared to be assembled upside-down with the arrow pointed toward the wing cap instead of the t tube connector.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿directions for use: 1.Separate notches within circles.Put straps through holes and around leg.2.Position bag on leg with flutter valve at top.3.Insert connector into proximal (drainage) end of t-tube.4.To empty bile bag, remove rubber cap at bottom.Important: hold green connector firmly while removing rubber cap.5.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 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 print on the bile bag appeared to have been assembled upside down.

• Brand Name: DAVOL BILE BAG, REGULAR
• Common Device Name: BILE BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8232835
• Report Number: 1018233-2019-00203
• Device Sequence Number: 10817162
• Product Code: FGE
• UDI-Device Identifier: 00801741011610
• UDI-Public: (01)00801741011610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 05/31/2023
• Device Model Number: 0015850
• Device Catalogue Number: 0015850
• Device Lot Number: NGCS3083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1