MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 100CC SILICONE CLOSED WOUND SUCTION EVACUATOR WITH ANTI-REFLUX VALVE

Catalog Number	0070740
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter's phone number that was provided was (b)(6).The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections 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.
Event or Problem Description
It was reported that during use the evacuator valve inside was broken and photo attached.The user was exposed to bodily fluid.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, f, h udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that during use the evacuator valve inside was broken and photo attached.The user was exposed to bodily fluid.Per follow up information received via ibc on 30jul2025, stated that no patient impacted and no serious injuries that occur to the patient.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one opened (without original packaging), used bulb evacuator wound drainage.Visual inspection of the one-photo sample noted that the valve was broken and inside the bulb evacuator.This does not meet specification which states "missing, damaged, leaking, torn, broken, incomplete or incorrect components are not permitted; the clamp must be closed".Product labeling was reviewed for this investigation.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that during use the evacuator valve inside was broken and photo attached.The user was exposed to bodily fluid.Per follow up information received via ibc on 30jul2025, stated that no patient impacted and no serious injuries that occur to the patient.

• Brand Name: 100CC SILICONE CLOSED WOUND SUCTION EVACUATOR WITH ANTI-REFLUX VALVE
• Common Device Name: CLOSED WOUND SUCTION
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22667921
• Report Number: 1018233-2025-06312
• Device Sequence Number: 15315814
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569(11)241019(17)290831(10)NGJW3145
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2025

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 Catalogue Number: 0070740
• Device Lot Number: NGJW3145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 10/28/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/05/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2024
• 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