MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN PHILLIPS FOLLOWER URETHRAL CATHETER 8 FR., STERILE

Model Number 021508

Device Problems Expiration Date Error (2528); Inaccurate Information (4051)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the expiration date on the back label of the product did not match with the date on the analytical certificate.Certificate expiration date lot: gfdp1338 ref (b)(4) exp.Date.31-mar-2024.Label expiration date lot: gfdp1338 ref (b)(4) exp.Date.Apr-2024.It was also stated that the label to the customer was referred in spanish.According to the quality team in (b)(6): - this label is applied on the dc in (b)(6), according to the nationalization process based on (b)(6) regulation.- the information of expiration date that goes on this label, comes from sap.However for legacy bard products the information inserted in sap is done manually.- the analytical certificate comes from the manufacturing plant.

Event Description

It was reported that the expiration date on the back label of the product did not match with the date on the analytical certificate.Certificate expiration date lot: gfdp1338, ref: 021508, exp.Date.31-mar-2024.Label expiration date lot: gfdp1338, ref: 021508, exp.Date.Apr-2024.It was also stated that the label to the customer was referred in spanish.According to the quality team in mexico: this label is applied on the dc in mexico, according to the nationalization process based on mexican regulation.The information of expiration date that goes on this label, comes from sap.However for legacy bard products the information inserted in sap is done manually.The analytical certificate comes from the manufacturing plant.

Manufacturer Narrative

The reported event was confirmed.A photo sample of the product label and the glens falls certificate of analysis of lot gfdp1338 were returned with different expiration dates.The certificate contained an expiration date of 31march2024, while the product label contained an expiration date of apr2024.Based on the correspondences in the complaint record, it appears that the product label was placed on the device by the mexican ibc in order to align with mexican regulation and the certificate of analysis came from glens falls.There appears to have been a planned deviation to remove labels and ensure the expiration date aligns with the certificate of analysis.However, this product catalog # was not considered for the rework and inspection.A potential root cause could be due to the jde expiration date being placed on the label.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as the reported event would not be caused by the user.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.

• Brand Name: BARD WOVEN PHILLIPS FOLLOWER URETHRAL CATHETER 8 FR., STERILE
• Type of Device: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10511084
• MDR Text Key: 207719830
• Report Number: 1018233-2020-05780
• Device Sequence Number: 1
• Product Code: FBW
• UDI-Device Identifier: 00801741072932
• UDI-Public: (01)00801741072932
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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
• Device Operator: Other
• Device Model Number: 021508
• Device Catalogue Number: 021508
• Device Lot Number: GFDP1338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 01/30/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1