MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR, 100ML CAPACITY

Model Number	0070850
Medical Device Problem Codes	Component Missing (2306); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
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.The device was not returned.
Event or Problem Description
It was reported that parts of the evacuator device were missing.So it could not used.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), unused bulb evacuator.Visual inspection of the sample noted that one end of the evacuator was missing the strap and cap that was to go on the bottom of the evacuator.This does not meet the specification "no damaged or missing components are permitted." a potential root cause for this failure could be ¿incorrect assembly operation of cap / bulb (incorrect assembly)." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that parts of the evacuator device were missing.So it could not be used.

• Brand Name: RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR, 100ML CAPACITY
• Common Device Name: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11802953
• Report Number: 1018233-2021-02708
• Device Sequence Number: 4689241
• Product Code: GCY
• UDI-Device Identifier: 00801741049613
• UDI-Public: (01)00801741049613
• 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: other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 0070850
• Device Catalogue Number: 0070850
• Device Lot Number: NGEP3445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other