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

Model Number	0070440
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
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 small broken pieces were found upon removal of silicone flat drain on (b)(6) 2021 which was placed on (b)(6) 2021.On (b)(6) 2021 they noted weakness and tear at base of silicone area without holes.And the third incident was about the drain tearing upon removal at the base.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿drain was manufactured incorrectly (dimensions or material not to spec, not cured for the appropriate amount of time etc.) ¿.The lot number is 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that small broken pieces were found upon removal of silicone flat drain on (b)(6) 2021 which was placed on (b)(6) 2021.On (b)(6) 2021 they noted weakness and tear at base of silicone area without holes.And the third incident was about the drain tearing upon removal at the base.

• Brand Name: HUBLESS FLAT SILICONE DRAIN
• Common Device Name: HUBLESS FLAT SILICONE DRAIN
• 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: 11886788
• Report Number: 1018233-2021-03038
• Device Sequence Number: 17085427
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0070440
• Device Catalogue Number: 0070440
• 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: 05/03/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 11/30/2021
• 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: Required Intervention
• Patient Sex: Unknown