MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HUBLESS SILICONE FLAT DRAIN; WOUND DRAINAGE

Model Number 0070440

Device Problems Material Protrusion/Extrusion (2979); Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

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 there was a little piece of plastic hanging down from the drain and it was not used on a patient.

Event Description

It was reported that there was a little piece of plastic hanging down from the drain and it was not used on a patient.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.One sample exhibited the reported failure.The device had not met specifications.The product was not used for patient treatment or diagnosis.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), unused hubless silicone drain.Visual inspection of the sample noted that there was flash on the side of the silicone drain.This does not meet the specification "visually inspect for: rough surfaces, jagged end cuts, kinks, tears and surfaces free from blemishes, grease." a potential root cause for this failure could be ¿incorrect parameters¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labelling 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: HUBLESS SILICONE FLAT DRAIN
• Type of Device: WOUND DRAINAGE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12674067
• MDR Text Key: 277698625
• Report Number: 1018233-2021-06522
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0070440
• Device Catalogue Number: 0070440
• Device Lot Number: NGEZ2936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other